GALT-immune by Energetix

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Serving Size 3 Capsule(s)

Ingredients	Amount Per Serving
Colostrum (pasteurized cow pre-Milk) (Colostrum (Form: pasteurized cow pre-Milk) )	900 mg
Beta Glucans (from Saccharomyces cerevisiae) (Beta Glucans (Form: from Saccharomyces cerevisiae Genus: Saccharomyces Species: cerevisiae) )	300 mg
hydrolyzed Fish Collagen	300 mg

Other Ingredients

Rice Starch, Rosemary (Rosmarinus officinalis) leaf extract PlantPart: leaf Genus: Rosmarinus Species: officinalis, Lemon (Citrus x limon) peel powder PlantPart: peel Genus: Citrus Species: x limon, Capsule (Form: Hydroxypropyl Methylcellulose, purified Water), Silicon Dioxide (Alt. Name: SiO2)

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Effectiveness view details

Below is general information about the effectiveness of the known ingredients contained in the product GALT-immune. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETA-GLUCANS (Beta Glucans)

LIKELY EFFECTIVE

Coronary heart disease (CHD). Consuming products containing at least 3.6 grams of soluble fiber, including beta-glucans, per day may reduce the risk of CHD when consumed as part of a diet low in saturated fat and cholesterol. Details: Clinical research shows that a diet containing foods high in beta-glucans, such as oats and barley, reduces the risk of heart disease (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the FDA approved a health claim stating that consuming products containing at least 3 grams of beta-glucans per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
Dyslipidemia. Oral beta-glucans modestly reduces low-density lipoprotein (LDL) cholesterol levels. Details: Although some research disagrees, most clinical research shows that taking barley- or oat-derived beta-glucans 3-10 grams daily for up to 12 weeks or yeast-derived beta-glucans 7.5 grams twice daily for 7-8 weeks can reduce LDL and total cholesterol levels when used for up to 12 weeks (5790,5796,7272,17129,34700,34727,34729,34765,34766,34811)(34812,34876). Meta-analyses of available clinical research on oat-derived beta-glucans show that taking at least 3 grams daily reduces LDL cholesterol by around 4-10 mg/dL and total cholesterol by 4-12 mg/dL but does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels when compared with control diets (92660,97987,112225). Consuming oat-derived beta-glucans also reduces apolipoprotein B (apoB) levels by 0.54 mg/dL when compared with control diets (97987). The effects of oat-derived beta-glucans on cholesterol levels appear to be greater in patients with diabetes and those with higher LDL cholesterol levels (92660,97987). A meta-analysis of available clinical research on barley-derived beta-glucans shows that consuming an average of 6.5-7 grams of beta-glucans daily as part of the diet reduces LDL cholesterol levels by 4.5 mg/dL, total cholesterol levels by 5.6 mg/dL, and apoB levels by 0.54 mg/dL when compared with control diets (98204). The form of beta-glucans used may alter the effect of beta-glucans on cholesterol levels. Some research shows that barley that is highly enriched (75% by weight) with beta-glucans does not significantly affect cholesterol levels. This lack of effect seems to be the result of processing the barley into a highly enriched beta-glucans product (10166). Other clinical research also shows that the processing of beta-glucans products or the food matrix used to make these products might reduce beta-glucans molecular weight and/or solubility and therefore decrease its ability to lower cholesterol levels (10145,34800,34819).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Aging. Although there is interest in using oral or topical beta-glucans for aging, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
Allergic rhinitis (hay fever). It is unclear if oral beta-glucans are beneficial for reducing symptoms of allergic rhinitis. Details: A small clinical trial in patients allergic to ragweed shows that taking specific yeast-derived beta-glucans (Wellmune WGP) 250 mg daily for 4 weeks decreases the number of allergy symptoms by 28% and the severity of allergy symptoms by 52% when compared with placebo (34859).
Atopic dermatitis (eczema). It is unclear if topical beta-glucans are beneficial for atopic dermatitis. Details: Preliminary clinical research in children and adults with atopic dermatitis shows that applying a specific cream (Imunoglukan P4H, PLEURAN s.r.o.) containing beta-glucans 0.25% 2-3 times daily for 6 months modestly reduces pruritus, intensity of flares, and overall disease severity when compared with the application of a standard emollient (98201).
Benign prostatic hyperplasia (BPH). Although there is interest in using oral beta-glucans for BPH, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
Cancer. Although there is interest in using oral beta-glucans for cancer, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Canker sores. It is unclear if oral beta-glucans are beneficial for canker sores. Details: Preliminary clinical research shows that taking beta-glucans 10 mg twice daily for 20 days reduces ulcer severity in patients with recurrent aphthous stomatitis when compared with placebo (34763).
Chronic fatigue syndrome (CFS). Although there is interest in using oral beta-glucans for CFS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Critical illness (trauma). It is unclear if oral beta-glucans are beneficial for patients with critical illness. Details: Preliminary clinical research shows that taking oat-derived beta-glucans 3 grams daily as part of enteral feeds does not reduce the length of hospital stay, mortality rate, or infection rate when compared with placebo in patients with trauma. However, the length of time on mechanical ventilation was approximately 47% shorter when compared with placebo (100186).
Diabetes. Small clinical studies in children and adults with type 1 diabetes suggest that beta-glucans do not improve blood glucose levels. It is unclear if oral beta-glucans are beneficial for patients with type 2 diabetes. Details: Some preliminary clinical research in adults with type 2 diabetes shows that consuming oat-derived beta-glucans 3 grams daily in bread for 3 weeks improves insulin resistance and cholesterol levels when compared with control bread (34765). Other preliminary clinical research in patients with type 2 diabetes shows that consuming bread containing oat-derived beta-glucans in a ratio of 7.6 grams per 100 grams of starch daily for 6 months reduces postprandial glucose levels and glycated hemoglobin (HbA1c) when compared with control bread (97986). Additionally, some clinical research shows that replacing a half serving of white rice with beta-glucans-containing barley attenuates increases in postprandial glucose and insulin levels when compared with a full serving of white rice in patients with type 2 diabetes (103887). However, oat-derived beta-glucans 3-3.5 grams daily in bread or soup for 3-8 weeks does not seem to significantly affect fasting plasma glucose levels or HbA1c when compared with control bread or soup (34765,34788). Also, some evidence shows that consuming soup enriched with beta-glucans does not improve cholesterol levels in patients with type 2 diabetes when compared with control soup (34788). The inconsistency in clinical outcomes may be due to differences in the length of treatment, quantity or ratio of beta-glucans consumed, and/or the preparation of the beta-glucans product. In children with type 1 diabetes, consuming a bedtime snack enriched in beta-glucans appears to prevent hypoglycemia prior to midnight, but does not prevent hypoglycemia at later time points when compared with a control snack (34685). In adolescents with type 1 diabetes, a very small clinical study shows that taking a specific oat product (Betaglucare), providing 6 grams beta-glucans, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with 3 grams beta-glucans daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the durations of hypoglycemia or hyperglycemia between groups (105261). However, a small crossover study in adults with type 1 diabetes shows that taking a specific product (Stomacol, Brainbridge Commerce AB) containing beta-glucans 1.53 grams 3 times daily prior to meals for 2 weeks does not alter blood glucose levels when compared with placebo (97983).
Exercise-induced respiratory infections. There is conflicting evidence about the effects of beta-glucans on respiratory infections in athletes following competitive events. Details: Taking a specific product containing oat beta-glucans (OatVantage) 5.6 grams daily for 14 days does not reduce the number of sick days or the number of upper respiratory tract infections in trained male cyclists when compared with placebo (34746). However, other clinical research shows that taking yeast-derived beta-glucans 250-500 mg daily for 4 weeks beginning on the day after a marathon reduces the occurrence of symptomatic upper respiratory infections by 33% to 50% within 2-4 weeks of treatment when compared with placebo. Health scores, fatigue, and mood also improved (34860,92659). Additional clinical research in marathon runners shows that drinking a beverage containing yeast-derived beta-glucans 250 mg daily for 45 days prior to, the day of, and 45 days after a marathon does not reduce the duration or number of upper respiratory infections, but does seem to reduce the number of symptomatic days and overall severity of upper respiratory symptoms, when compared with placebo (103886). Finally, clinical research in top athletes also shows that taking a specific product containing mushroom-derived beta-glucans (Imunoglukan P4H, PLEURAN s.r.o.) 200 mg with vitamin C 200 mg daily for 3 months reduces the number of subjects with at least four symptoms of upper respiratory tract infection by approximately 85% when compared with vitamin C alone (34809).
Fibromyalgia. Although there is interest in using oral beta-glucans for fibromyalgia, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Hepatitis. Although there is interest in using oral beta-glucans for hepatitis, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Hypertension. It is unclear if oral beta-glucans are beneficial for hypertension; the available evidence is conflicting. Details: Preliminary clinical research shows that consuming an oat cereal containing beta-glucans 5.52 grams daily for 6 weeks reduces diastolic and systolic blood pressure when compared with a low-fiber cereal in hypertensive adults (34691). However, other clinical research shows that consuming oat-based cereals enriched in beta-glucans for 12 weeks does not reduce blood pressure in individuals with hypertension. A reduction in blood pressure occurred in a sub-group of these individuals with a body mass index greater than 31.5 kg/m2 (34684,34722).
Inflammatory bowel disease (IBD). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in adults with IBD and symptoms of irritable bowel syndrome shows that taking a combination of beta-glucans, inositol, and digestive enzymes daily for 4 weeks, in conjunction with mesalamine, reduces evacuative urgency when compared with mesalamine alone. Taking this combination product also reduces abdominal pain, bloating, and gas when compared with baseline, but not when compared with taking mesalamine alone (97984).
Irritable bowel syndrome (IBS). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking one pill twice daily of a specific combination product (Biointol, BioActivaL) containing beta-glucans, inositol, and digestive enzymes for 4 weeks reduces pain, bloating, and gas, but not other symptoms of IBS, when compared with no treatment (34818). It is not clear if these effects are due to beta-glucans, the other ingredients, or the combination.
Laser skin resurfacing. It is unclear if topical beta-glucans are beneficial for improving recovery from laser skin resurfacing. Details: In patients that had received fractional laser therapy for atrophic acne scars, preliminary clinical research shows that topical application of skin care products containing beta-glucans, including dressings, solutions, and creams, (Dermdoc, Songyang Biotechnology Co. Ltd) once daily to one side of the face for 14 days modestly increases hydration and reduces redness when compared with the other side of the face treated with the vehicle alone (105263).
Lower respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of lower respiratory tract infections when compared with no treatment. In the four months after treatment completion, the number of infections was reduced by about 50%; however, the total number of infections in each group was small. The dose was 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
Lyme disease. Although there is interest in using oral beta-glucans for Lyme disease, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Metabolic syndrome. It is unclear if oral beta-glucans are beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome or at high risk for metabolic syndrome shows that eating 200 grams of bread enriched with 6% barley-derived beta-glucans daily for 4 weeks as part of the diet does not alter most metabolic parameters when compared with baseline. However, there was a small reduction in total cholesterol (100185). The validity of this finding is limited by the lack of a comparator group.
Multiple sclerosis (MS). Although there is interest in using oral beta-glucans for MS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Neuroblastoma. It is unclear if oral beta-glucans is beneficial in children or young adults with neuroblastoma. Details: Clinical research in children and young adults with relapsed or refractory high-risk neuroblastoma shows that taking yeast-derived beta-glucans for 17 days, starting four days before treatment with intravenous anti-GD2 murine monoclonal antibody for a total of 10 days, results in progression-free and overall survival rates of 28% and 61%, respectively, after 2 years, and 19% and 36%, respectively, after 5 years. Doses of beta-glucans ranged from 10-200 mg/kg daily and each patient completed 1-4 treatment cycles (109203). The validity of these findings is limited by the lack of statistical comparison to a control group. A large clinical study in children and young adults with high-risk neuroblastoma receiving subcutaneous GD2/GD3 vaccine shows that taking beta-glucans 40 mg/kg/day for 14 days as a primer to the vaccine improves the IgG antibody response at 32 weeks when compared with controls who started taking beta-glucans 6 weeks after vaccination. However, taking beta-glucans prior to vaccination does not improve overall or progression-free survival at approximately 20 months (112227). This study may have been inadequately powered to detect a difference in survival between groups.
Obesity. It is unclear if oral beta-glucans are beneficial for obesity. Details: A meta-analysis of 20 randomized controlled trials shows that taking beta-glucans reduces body weight by about 0.8 kg and body mass index (BMI) by about 0.6 kg/m2 when compared with not taking beta-glucans. However, there was no effect on waist circumference. Also, populations included in this meta-analysis included those with obesity, as well as healthy individuals and patients with diabetes or hypercholesterolemia (100183). Results from individual clinical trials are mixed, with some showing modest reductions in body weight, BMI, and/or waist circumference, and others showing no effect (34790,98202,98203,100183,109208). This research has evaluated barley-, oat-, or yeast-derived beta-glucans at doses between 0.88-9 grams daily for 0.4-12 weeks (34790,98202,98203,100183,109208). Also, a capsule containing yeast-derived beta-glucans 477 mg has been taken daily for 2 weeks, then twice daily for 4 weeks (98203). Beta-glucans have also been taken in combination with other ingredients. For example, barley-derived beta-glucans 2.2 grams has been mixed with rice and consumed twice daily with meals for 12 weeks (98202) and oat-derived beta-glucans (B-Can, Garuda International, Inc.) 2.5 grams has been taken with green coffee polyphenols 300 mg twice daily for 8 weeks (109208). The inconsistency in clinical outcomes may be due to the heterogenous patient populations, as well as the differing sources, doses, and dosage forms of beta-glucans used.
Otitis media. Although there is interest in using oral beta-glucans for otitis media, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Postoperative pain. It is unclear if oral beta-glucans are beneficial for reducing abdominal pain after surgery for intestinal polyps. Details: Preliminary clinical research in patients who underwent surgical removal of intestinal polyps shows that eating bread containing barley beta-glucans 3 grams daily for 3 months reduces bloating and abdominal pain when compared with eating bread that does not contain beta-glucans (34813).
Respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 reduces the duration of respiratory tract infections by about 1.7 days and modestly improves parent-perceived symptom severity and effectiveness when compared with no treatment. However, there was no effect on the number of total, upper, or lower respiratory tract infections, the use of antibiotics or antipyretics, or the number of days missed from school. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
Rheumatoid arthritis (RA). Although there is interest in using oral beta-glucans for RA, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
Stretch marks (striae distensae). It is unclear if topical beta-glucans are beneficial for stretch marks. Details: Preliminary clinical research shows that a specific topical serum and emulsion (Awake; Hangzhou Songyang Biotechnical) containing beta-glucans, applied twice daily for 12 weeks, modestly improves patient-scored, but not physician-scored, stretch mark appearance when compared with a vehicle control. When beta-glucans are used in combination with 1565-nm non-ablative fractional laser once every 4 weeks for 12 weeks, scar atrophy is modestly improved when compared with either treatment alone (109210). However, it is unclear if any changes would be considered clinically significant.
Upper respiratory tract infection (URTI). It is unclear if oral beta-glucans are beneficial for the prevention of URTIs in adults or children. Details: A meta-analysis of clinical research shows that taking yeast-derived beta-glucans reduces the odds of developing a URTI in generally healthy individuals by approximately 65% when compared with placebo. There was also a small to medium effect on the overall incidence and duration of URTIs. Doses ranged from 35-900 mg daily for 4-26 weeks (105264). However, the results from this analysis were heterogeneous and the number of studies included was small. One study included in the analysis used a specific product containing yeast-derived beta-glucans (Wellmune WGP) 500 mg daily for 12 weeks and found no effect on the number or duration of overall symptomatic infections or the number or duration of specific types of respiratory infections when compared with placebo. However, there was an improvement in quality of life and a reduction in the number of missed work days (34879). Beta-glucans have also been evaluated for the prevention of URTI in children. A small clinical study in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of upper respiratory tract infections when compared with no treatment. At four months after treatment completion, the number of infections was reduced by about 44%; however, the total number of infections in both groups was small. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
Wound healing. Although there is interest in using topical beta-glucans for healing of wounds, burns, skin ulcers, and dermatitis, there is insufficient reliable information about the clinical effects of beta-glucans for these purposes. More evidence is needed to rate beta-glucans for these uses.

(Read more about BETA-GLUCANS)

BOVINE COLOSTRUM (Colostrum)

POSSIBLY EFFECTIVE

Diarrhea. Oral hyperimmune bovine colostrum seems to help prevent infectious diarrhea and reduces the duration of infectious diarrhea in children. Details: An open-label study in children aged 1-6 years with a history of recurrent diarrhea shows that taking hyperimmune bovine colostrum daily for 4 weeks decreases the number of infectious diarrhea episodes during a 6-month period by around 2 episodes when compared to baseline (95924). Clinical research in infants also shows that drinking formula containing hyperimmune bovine colostrum for 1 week decreases the frequency of infectious diarrhea at 6 months by 1.5 episodes when compared to baseline (101801). Taking bovine colostrum might also reduce the duration of infectious diarrhea related to Escherichia coli. Two small clinical studies in children aged 1 month to 18 years show that bovine colostrum reduces the duration of diarrhea caused by enterotoxigenic E. coli when compared with placebo (2067,101796). The studies used hyperimmune colostrum, which provides high antibody titers against organisms for which the cow has been immunized (4905). Doses studied include hyperimmune bovine colostrum 7 grams three times daily for 14 days in children aged 1 month to 18 years (2067); a specific hyperimmune bovine colostrum product (ImmuGuard, NMI) 3 grams daily if less than 2 years of age, or 3 grams twice daily if over 2 years of age, for 1-4 weeks (95924,101796); and infant formula containing hyperimmune bovine colostrum 0.5 grams/kg for one week (101801).
Exercise-induced respiratory infections. Small clinical studies suggest that oral bovine colostrum reduces the risk of exercise-induced respiratory infection in healthy adults. Details: While results from individual clinical studies are mixed (92413,92416), a meta-analysis of 5 small clinical trials in healthy adults shows that taking bovine colostrum 10 or 20 grams daily for 8-12 weeks during exercise training reduces the rate of upper respiratory symptom days by 44% and the rate of episodes of upper respiratory symptoms by 38% when compared with placebo (92417).
HIV/AIDS-related diarrhea. Small clinical studies suggest that oral bovine colostrum reduces the frequency of diarrhea in patients with HIV/AIDS-related diarrhea. Details: Several very small clinical trials in patients with HIV/AIDS-related diarrhea show that taking bovine colostrum daily for up to 3 weeks seems to reduce the frequency of diarrhea when compared to baseline (4905,4906,4907,4908,92415). The validity of these findings is limited by lack of control group. Hyperimmune bovine colostrum had FDA orphan status for HIV-related diarrhea (9840); however, it has not been FDA-approved for this indication. Most clinical trials have used colostrum from pregnant cows that have been immunized against specific pathogens. The hyperimmune colostrum provides high antibody titers against organisms for which the cow has been immunized (4905). Specific hyperimmune colostrum products showing benefit include ColoPlus by ColoPlus AB and Lactobin by Biotest AG (4907,92415).
Rotaviral diarrhea. Small clinical studies suggest that oral hyperimmune bovine colostrum is effective for treating rotaviral diarrhea in infants and children. Details: Several small clinical studies in infants and children with rotaviral diarrhea show that taking hyperimmune bovine colostrum decreases stool frequency and volume and speeds up the clearance of rotavirus when compared with placebo or baseline (4903,4904,4909,36999,37022,101796). Most clinical trials have used colostrum from pregnant cows that have been immunized against specific pathogens. This hyperimmune colostrum provides high antibody titers against organisms for which the cow has been immunized (4905). Doses studied include hyperimmune bovine colostrum powder 10 grams daily in divided doses for 4 days, hyperimmune bovine colostrum 100 mL three times daily for 3 days, and hyperimmune bovine colostrum 20 mL daily for 2 weeks in infants and children up to 30 months old (4903,4904,4909,36999). A specific hyperimmune bovine colostrum product (ImmuGuard, NMI) 3 grams daily if less than 2 years of age, or 3 grams twice daily if over 2 years of age, for 1 week has also been used (101796).

POSSIBLY INEFFECTIVE

Necrotizing enterocolitis (NEC). Small clinical studies suggest that oral bovine colostrum does not prevent NEC in preterm or very low birth weight infants. Details: A small clinical study in very low birth weight infants shows that giving bovine colostrum (Pedimmune, Merk India Ltd.) 1.2 or 2 grams enterally four times daily until discharge or death does not reduce the risk of NEC when compared with placebo (92411). Another small clinical study in formula-fed, preterm neonates also shows that giving bovine colostrum (Immuguard, Dulex-Lab) for 2 weeks has no effect on the incidence of NEC when compared with a control group (105755). An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not reduce the risk of NEC when compared with a conventional milk fortifier (111140). Additionally, a large clinical study in very preterm infants shows that adding bovine colostrum to breastmilk feeding during the first 14 days of life does not reduce the risk of NEC or shorten the time to full enteral feeding when compared with preterm formula added to breastmilk (114816).
Sepsis. Small clinical studies suggest that oral bovine colostrum does not prevent sepsis in preterm or very low birth weight infants. Details: A small clinical study in low birth weight infants shows that giving bovine colostrum (Pedimmune, Merk India Ltd.) 1.2 or 2 grams enterally four times daily until discharge or death does not reduce the risk of sepsis when compared with placebo (92411). Another small clinical study in formula-fed, preterm neonates also shows that giving bovine colostrum (Immuguard, Dulex-Lab) for 2 weeks has no effect on the incidence of late-onset sepsis when compared with a control group. While the severity of sepsis appeared to be higher in the control group, the study was underpowered to assess this outcomes (105755). An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not reduce the risk of sepsis when compared with a conventional milk fortifier (111140).
Short bowel syndrome. Small clinical studies suggest that oral bovine colostrum is not beneficial in children or adults with short bowel syndrome. Details: A very small crossover study in children with short bowel syndrome shows that administering bovine colostrum enterally at a dose that comprises 20% of a child's daily basal fluid requirement does not improve growth or intestinal function when compared with a control diet (92410). Another very small crossover study in adults with short bowel syndrome shows that taking bovine colostrum 250 mL twice daily for 4 weeks does not improve intestinal absorption or body composition when compared with an isocaloric control supplement (92423).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Aging. Although there has been interest in using oral bovine colostrum for aging, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Athletic performance. Small clinical studies suggest that oral bovine colostrum might improve some measures of athletic performance; however, results are mixed, and any benefit appears to be small. Details: Several small clinical studies show that taking bovine colostrum 10-60 grams daily for up to 8 weeks increases power and improves cycling and sprint time following an initial bout of exercise, but not during a normal training period (11453,16532,36988,36991,36995). Another small clinical study in elite soccer players shows that a lower dose of 3.2 grams daily for 6 weeks modestly attenuates muscle damage, muscle soreness, and decreases in squat jump performance after simulated soccer matches (98820). However, bovine colostrum does not appear to improve rowing performance, anaerobic work capacity, endurance, or strength training (11453,16532,36980,36992,36995,37000,37006,92419,114817). Differences are possibly explained by the variation in exercise and recovery protocols used (16533).
Autism spectrum disorder. Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A very small clinical trial in children aged 3-11 years with autism spectrum disorder shows that taking bovine colostrum (Immucon) 5.1-10.8 grams daily with Bifidobacterium infantis for 5 weeks improves measures of irritability and hyperactivity and symptoms of autism-associated gastrointestinal problems such as stool consistency and frequency of diarrhea when compared to baseline (101792). The validity of these findings is limited by a lack of placebo control. Also, it is unclear if these findings are due to bovine colostrum, Bifidobacterium infantis, or the combination.
Benign prostatic hyperplasia (BPH). Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in males with lower urinary tract symptoms related to BPH shows that taking bovine colostrum 30 mg and saw palmetto extract 320 mg plus tamsulosin 0.4 mg daily for 12 months does not improve overall symptoms when compared with tamsulosin alone. However, the combination improved storage symptoms more than tamsulosin alone, without affecting urinary flow rate, postvoid residual volume, or prostate volume (101795). This study is limited by the lack of a placebo group.
Chemotherapy-related infection. It is unclear if oral bovine colostrum is effective for the prevention of chemotherapy-related infection. Details: A small clinical study in children with leukemia shows that taking bovine colostrum (Biofiber-Damino) 0.5-1 gram/kg daily during chemotherapy treatment for 4 weeks does not reduce the incidence of fever, neutropenic fever, bacteremia, fungaemia, or the need for antibiotics when compared with placebo (101797). It is possible that this study was underpowered to detect between-group differences.
Child growth. Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical trial in 9-month-old breastfed infants at high risk for stunted growth shows that giving bovine colostrum 5.7 grams with whole egg powder 4.3 grams twice daily for 3 months reduces stunting and linear growth faltering, as measured by mean length-for-age z-score, when compared with placebo. These effects are sustained for up to 5 months following discontinuation of bovine colostrum (105754). It is unclear if these effects are due to bovine colostrum, whole egg powder, or the combination.
Cognitive function. It is unclear if oral bovine colostrum is effective for improving cognitive function. Details: A small clinical study in older adults shows that taking a specific bovine colostrum product (Eterna Gold, Saskatoon Colostrum Co. Ltd.) 60 grams daily for 8 weeks does not improve cognitive function when compared with whey protein (92414).
Critical illness (trauma). It is unclear if oral bovine colostrum is beneficial in patients with critical illness. Details: A small clinical trial in critically ill patients shows that taking bovine colostrum 20 grams daily in enteral formula reduces the median length of stay by around 7 days and reduces risk of diarrhea by 72% when compared with placebo. There was no effect on vomiting, abdominal distention, constipation, sepsis, or mortality (101799).
Dental plaque. Although there has been interest in using topical bovine colostrum for dental plaque, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Diabetes. It is unclear if oral bovine colostrum is beneficial in patients with type 2 diabetes. Details: A very small clinical study in patients with type 2 diabetes shows that taking bovine colostrum (Immuno-Dynamics, Inc.) 5 grams twice daily on an empty stomach for 4 weeks decreases postprandial blood glucose by 11% to 14% and cholesterol levels by 8% when compared to baseline (92418). The validity of these findings is limited by a lack of comparator group.
Dry eye. Although there has been interest in using topical bovine colostrum for dry eye, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Graft-versus-host disease (GVHD). Although there has been interest in using oral bovine colostrum for diarrhea associated with GVHD, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Hematopoietic stem cell transplant (HSCT). Oral and topical bovine colostrum have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: A small clinical study in patients undergoing HSCT shows that taking a specific combination product containing bovine colostrum and aloe (Remargin Colostrum Gastro-Gel, Solimè srl) and rinsing with a specific mouthwash containing bovine colostrum and aloe (Remargin Colostrum OS, Solimè srl) modestly reduces the risk and duration of severe oral mucositis and febrile neutropenia when compared with historical values. There was no effect on duration of neutropenia, length of hospital stay, pain, or duration of medication use. All patients were also given standard care. The mouthwash was used after each oral hygiene session, and the oral treatment was taken 3 to 5 times daily depending on symptoms (110211,111135). The validity of these findings is limited by a lack of control group. Additionally, it is unclear if these findings are due to bovine colostrum, aloe, or the combination.
Human papillomavirus (HPV). It is unclear if intravaginal bovine colostrum is beneficial in patients with HPV infection. Details: Observational research in patients with HPV infection has found that vaginal application of bovine colostrum-containing tablets (Ginedie, Tfarma) twice weekly for 6 months is associated with regression of low grade cervical lesions in 76% of patients (92424). The validity of these findings is limited by the observational nature of the study and a lack of comparator group.
Influenza. It is unclear if oral bovine colostrum is effective for the prevention of influenza in adults. Details: A small clinical study in healthy Italian adults shows that taking a specific type of defatted freeze-dried bovine colostrum (ARd Colostrum, Corcon srl) 400 mg daily for 8 weeks reduces the rate of self-reported flu symptoms by approximately 70% to 75% when compared with no prophylaxis or receiving the influenza vaccine. In high-risk patients with cardiovascular disease, taking bovine colostrum, with or without influenza vaccination, reduces the rate of self-reported flu symptoms by up to 22% when compared with vaccination alone. However, viral testing was not conducted and some patients reported more than one incidence of flu symptoms during the study period, indicating that the reported symptoms might not have been caused by influenza infection (92412).
Lichen planus. Although there has been interest in using topical bovine colostrum for lichen planus, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Malnutrition. It is unclear if oral bovine colostrum is beneficial in children with malnutrition. Details: A small clinical study in children with nonorganic failure to thrive shows that taking bovine colostrum 40 mg/kg daily for 3 months, along with routine treatment, modestly increases weight but not height when compared with routine treatment alone. Failure to thrive resolves in approximately 10-fold more patients treated with bovine colostrum and routine treatment when compared with routine treatment alone (92420).
Multiple sclerosis (MS). It is unclear if oral bovine colostrum is beneficial in patients with MS. Details: A very small clinical study in patients with MS shows that taking hyperimmune bovine colostrum 100 mL daily for about 4 weeks improves symptoms of MS when compared with non-hyperimmune bovine colostrum (37039). However, another very small clinical study in patients with MS shows that taking hyperimmune bovine colostrum about 120 mL daily for 4 weeks does not improve symptoms of MS when compared with placebo (37024).
Muscle strength. Although there has been interest in using oral bovine colostrum for muscle strength, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Oral mucositis. It is unclear if oral bovine colostrum is effective for the prevention of chemotherapy-induced oral mucositis. Details: A small clinical study in children with leukemia shows that taking bovine colostrum (Biofiber-Damino) 0.5-1 gram/kg daily during chemotherapy for 4 weeks reduces the peak severity of oral mucositis, but not the overall risk of oral mucositis, when compared with placebo (101797).
Physical performance. It is unclear if oral bovine colostrum is effective for improving physical performance in older adults. Details: A small clinical study in older adults participating in resistance training shows that taking a specific bovine colostrum product (Eterna Gold, Saskatoon Colostrum Co. Ltd.) 60 grams daily for 8 weeks might improve leg strength, but not upper body strength or body composition, when compared with placebo (92414).
Prematurity. It is unclear if oral bovine colostrum improves outcomes in very preterm infants. Details: An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not increase weight, length, or head circumference, but slightly improves bowel habits, when compared with a conventional milk fortifier (111140,111141). A large, multi-center, clinical study conducted in 7 neonatal intensive care units in China among very preterm infants shows that adding bovine colostrum to breastmilk, when maternal milk supply was insufficient, until postnatal day 14does not reduce time to full enteral feeding, feeding intolerance, risk of morbidity or mortality, or improve infant growth when compared with preterm formula added to breastmilk (114816). However, results significantly varied by study site where different feeding protocols were used. Additionally, blinding of clinical personnel was inadequate due to color, odor, and viscosity differences between bovine colostrum and preterm formula.
Psychological well-being. Although there has been interest in using oral bovine colostrum for psychological well-being, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Shigellosis. It is unclear if oral bovine colostrum is beneficial in children with shigellosis. Details: A small clinical study in children aged 1-12 years with shigellosis shows that taking hyperimmune bovine colostrum 100 mL three times daily for 3 days along with the antibiotic pivmecillinam for 5 days does not reduce the duration of Shigella dysenteriae infection when compared with a control group taking non-hyperimmune bovine colostrum and pivmecillinam (36986).
Sjogren syndrome. Although there has been interest in using topical bovine colostrum for Sjogren syndrome, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Travelers' diarrhea. Several very small clinical studies suggest that oral hyperimmune bovine colostrum is beneficial for the prevention of travelers' diarrhea in adults. Details: Three very small clinical studies in healthy adults show that taking hyperimmune bovine colostrum reduces the risk of diarrhea due to pathogens that commonly cause travelers' diarrhea such as enterotoxigenic Escherichia coli (2068,2069) and Shigella flexneri (2070).
Ulcerative colitis. It is unclear if rectal bovine colostrum is beneficial in patients with ulcerative colitis. Details: A very small clinical study in patients with distal ulcerative colitis shows that rectal administration of bovine colostrum 10% solution, as an enema, twice daily along with oral mesalamine for 4 weeks improves symptom and histological scores when compared with a placebo enema plus mesalamine (9730).
Upper respiratory tract infection (URTI). It is unclear if oral bovine colostrum is effective for preventing or treating URTIs in children or adults. Details: A small clinical study in healthy adult males shows that taking a specific bovine colostrum product (Intact, Numico Research Australia Pty. Ltd.) 30 grams twice daily for 8 weeks reduces the incidence of URTIs by about 33% when compared with whey protein. However, it does not appear to reduce the duration of URTIs if they do occur (36998). However, another small clinical study in healthy medical and health sciences students shows that taking bovine colostrum 500 mg once or twice daily for 45 days, then again for 7 days starting at day 87, does not reduce the frequency or severity of URTI symptoms when compared with placebo (111139). In children aged 1-6 years with a history of recurrent URTIs, a small clinical study shows that taking hyperimmune bovine colostrum (ImmuGuard, NMI) 3 grams once or twice daily for 4 weeks decreases the occurrence of URTIs during a 6-month period by about 4 episodes when compared to baseline (95924). The validity of this finding is limited by the lack of a control group. However, another small clinical study in healthy children aged 3-7 years shows that taking bovine colostrum 500 mg twice daily for 15 days followed by 500 mg once daily for 30 days preventatively, and 500 mg twice daily for 4 days if URTI symptoms develped, does not decreases the frequency of days with any URTI symptoms and symptom severity over 21 weeks when compared with whey-based control. (114819). The validity of the study is limited by the lack of a true placebo and absence of investigator-rated outcomes. Frequency of URTIs and symptom severity was reported by the child's parents or guardians via online survey every 2-4 weeks throughout the duration of the trial.
Vaginal atrophy. Intravaginal bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in postmenopausal patients with vulvovaginal atrophy shows that inserting 2 mL of a combination cream (Refeel, IDI Pharma) containing bovine colostrum, visnadine, and prenylflavonoids into the vagina once daily for 15 days improves overall symptoms when compared to baseline (98819). A larger clinical study in postmenopausal patients shows that using an intravaginal gel containing bovine colostrum 2.3% and other ingredients (Monurelle Biogel, Zambon SpA) daily for 12 weeks improves overall vaginal health scores by approximately 54%, increasing the number of patients engaging in regular sexual activity to 84% from 59% at baseline. Use of the gel also appears to reduce urinary incontinence (101794). The validity of these findings is limited by the lack of control groups. Also, it is unclear if these effects are due to bovine colostrum, other ingredients, or the combination.
Wound healing. It is unclear if oral bovine colostrum is beneficial for wound healing. Details: A small non-randomized open-label intervention in patients with chronic non-healing wounds suggests that adding powdered bovine colostrum 500 mg to wound dressings for 21 days is associated with improved wound healing when compared with conventional wound dressings (114821). More evidence is needed to rate bovine colostrum for these uses.

(Read more about BOVINE COLOSTRUM)

COLLAGEN PEPTIDES (hydrolyzed Fish Collagen)

POSSIBLY EFFECTIVE

Aging skin. Oral collagen peptides seem to improve skin hydration and elasticity in older adults. However, it is unclear if any improvements related to wrinkles are cosmetically important. Details: Meta-analyses of the available research, as well as multiple individual clinical studies, show that collagen peptide products, taken in doses of 372 mg to 12 grams daily for 4-12 weeks, improve skin hydration and elasticity in older adults. Studied products include Peptan-F or Peptan-P (Rousselot), Wellnex (Nitta Gelatin), Gold Collagen Active (Minerva Research Labs), VERISOL (Gelita AG), and Nippi peptide FCP-EX (Nippi/Shizuoka) (97632,100703,101597,104647,107460,112457,115044). Pooled study results also suggest that hydrolyzed collagen sourced from fish improves skin hydration and elasticity, while collagen peptides originating from chickens seems to modestly improve skin elasticity but not hydration. Collagen peptides derived from bovine do not seem to improve skin hydration or elasticity (112457). Despite research showing improvement in skin hydration and elasticity, it is unclear if collagen peptides reduce skin wrinkles to a cosmetically significant degree, as most studies have not evaluated this outcome. In one clinical study, taking a freshwater fish-derived collagen peptide (Vinh Wellness Collagen, Vinh Hoan Corporation) 10 grams every morning reduced wrinkle count in the nasolabial region of the right side, but not the left side, of the face by 24% when compared with placebo. Collagen peptides did not improve participant-reported measures of wrinkles, elasticity, hydration, and others, when compared with placebo (104639). Another clinical study shows that taking a specific fish scale-derived collagen peptide (Wellnex, Nitta Gelatin) with either a high or low ratio of prolyl-hydroxyproline and hydroxylpropyl-glycine as 5 grams orally daily for 8 weeks modestly improves wrinkle depth and roughness, but not wrinkle volume, when compared with placebo. The product with a high ratio of dipeptides had a larger effect (97632). Also, one clinical study shows that taking a specific product containing porcine collagen type I peptides (VERISOL, Gelita AG) 2.5 grams daily for 8 weeks reduces eye wrinkle volume by 20% when compared with placebo (101648). Two similar moderate-size clinical studies in middle-aged adults with crow's feet wrinkles and dry skin show that taking specific low-molecular-weight fish-derived collagen peptide products (Geltech Co.; CPNS) at doses of 2000 mg or 1650 mg, respectively, daily for 12 weeks improves eye wrinkles, skin hydration, and elasticity when compared with placebo (110729,110730). While investigator satisfaction scores regarding wrinkle reduction were modestly improved, participant satisfaction was not improved (110729). A moderate-sized clinical study in middle-aged adults shows that taking a specific collagen peptide supplement (Peptan-P®, Rousselot) 5 grams daily for 12 weeks does not decrease the visibility of crow's feet wrinkles when compared with placebo (115044). Small clinical studies have shown contradictory findings when collagen peptides are taken in combination with other ingredients. In one clinical trial, a specific drink (Diva Luxe) providing fish collagen peptides 5.5 grams plus Chenopodium formosanum extract 1 gram daily for 8 weeks improved some measures of skin brightness and hydration, but not wrinkles and crow's feet, when compared with placebo (104646). Another small clinical study shows that taking collagen peptides 4 grams daily in combination with coenzyme Q10 50 mg, vitamin C, vitamin A, and biotin for 12 weeks reduces wrinkles and improves skin smoothness by a small amount when compared with placebo. However, there was no difference in skin elasticity or hydration (104638). A clinical study in older females shows that taking collagen peptides 9 grams in combination with zinc and vitamins A, C, and E daily for 90 days increases stratum corneum water content and skin viscoelasticity when compared with placebo. However, it is unclear if the improvement from baseline differed between groups. Small improvements in dermal echogenicity, wrinkles, or skin pores were noted in some facial regions, but the lack of statistical comparison to placebo limits the validity of these findings (107464). Some small clinical studies have shown mixed effects with low doses of collagen peptides from preliminary clinical research using BioCell Collagen (BioCell Technology, LLC) or Celergen (Laboratories-Dom) (28681,97930). It is unclear if any improvements from these studies are due to collagen peptides, other ingredients, or the combinations. Topical application of collagen peptides has been minimally evaluated. A very small observational study in older adults has found that application of a carbopol gel containing collagen peptides 1% to the periorbital area twice daily for 8 weeks is associated with increased skin hydration and elasticity and reduced transepidermal water loss, skin roughness, and wrinkles when compared with baseline (107459). The validity of these findings is limited by poor study methodology, lack of statistical comparison to baseline, and lack of a comparator group.
Dry skin. Oral collagen peptides seem to improve skin hydration and elasticity in adults with dry skin. However, their effect on other measures of dry skin is unclear. Details: A meta-analysis of 19 clinical studies, along with several small and moderate-sized individual studies, some of which are included in the meta-analysis, show that taking collagen peptides 372 mg to 12 grams daily for 4-12 weeks improves skin hydration and elasticity when compared with placebo in healthy adults (107461,110729,110730,112457,112458,115044). Some studies show that collagen peptides improve skin roughness (107461), decrease peeling (110729,110730), and increase stratum corneum and epidermis water content (107462) but not skin gloss (107461) or elasticity (107462). Some research shows that collagen peptides reduce transepidermal water loss (107462), while another study shows no change (107461). Subgroup analysis of the meta-analysis suggests that hydrolyzed collagen sourced from fish improves skin hydration and elasticity the most, while collagen peptides originating from chicken seem to modestly improve skin elasticity but not hydration. Collagen peptides from bovine do not seem to improve skin hydration or elasticity (112457). Studied products include FCP-Z (Nippi Co., Ltd), Geltech Co., CPNS, and GPVGPS Collagen (Daehan Chemtech) (107462,110729,110730,112458). Collagen peptides have also been evaluated in combination with other ingredients. A small clinical study in healthy adults with low skin moisture shows that drinking 30 mL of a beverage containing fish scale-derived collagen peptides 10 grams and ornithine 400 mg (FUJIFILM) daily for 8 weeks does not improve skin moisture but seems to improve skin elasticity and reduce water loss when compared with placebo (101607). Another very small clinical study in a mixed population of patients with dry skin and mild atopic dermatitis shows that twice daily application of an emollient containing collagen peptides, soluble proteoglycan, and hyaluronic acid for 4 weeks reduces itching severity from moderate at baseline to mild or almost none. Transepidermal water loss and skin hydration also improved when compared to baseline (107465). The validity of these findings is limited by the lack of a comparator group. Both of these studies are limited by their small size, and it is unclear if any improvements are due to collagen peptides, other ingredients, or the combination.

POSSIBLY INEFFECTIVE

Muscle strength. Most research suggests that oral collagen peptides do not improve leg strength. However, they may improve hand-grip strength and fat-free mass. Details: Small clinical studies in healthy male and female athletes or non-athletes undergoing resistance or other training show that taking collagen peptides 15-30 grams daily or after training sessions for up to 15 weeks, with or without vitamin C, does not improve leg strength (i.e. squat strength, knee extension, or flexor strength) when compared with placebo (101608,104641,107457,110668,110669). Similarly, 2 very small clinical studies in healthy adults show that taking a specific oral collagen peptide product (Bodybalance, Gelita AG) 5-15 grams daily while completing a resistance training program for 14-15 weeks increases patellar tendon cross-sectional area but does not improve most measures of tendinous tissue remodeling including patellar tendon size, vastus lateralis aponeurosis size, patellar tendon mechanical properties, tendon stiffness, maximal knee extension strength, or rectus femoris muscle cross-sectional area when compared with placebo (112452,112454). However, a small clinical study with the same product in untrained females aged 18-50 years shows that taking 15 grams daily in addition to resistance training three times weekly for 12 weeks improves hand-grip strength when compared with resistance training and placebo (101608). In untrained males aged 30-60 years, taking the same dose of this collagen peptide product along with resistance training for 12 weeks improves fat-free mass by 3 kg, compared with 2 kg with resistance training and placebo. A post-hoc exploratory analysis suggests that the effects seen in males are similar to those seen with whey protein (107457).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Acne. Although there has been interest in using oral collagen peptides for acne, there is insufficient reliable information about the clinical effects of collagen peptides for this condition.
Androgenic alopecia. Oral collagen peptides have only been evaluated in combination with other ingredients, their effect when used alone is unclear. Details: A moderate-sized clinical study in adults with androgenic alopecia or telogen effluvium shows that taking a combination product containing hydrolyzed collagen 300 mg, taurine, cysteine, methionine, iron, and selenium (GFM Oral, Cantabria Labs) daily along with conventional therapy, consisting primarily of finasteride or minoxidil, for 12 weeks improves hair loss when compared with conventional therapy alone (111636). It is unclear if this effect is due to collagen peptides, other ingredients, or the combination.
Athletic performance. It is unclear if oral collagen peptides improve performance in most athletes. Details: In recreationally active female runners undergoing resistance and endurance training 3 times weekly, clinical research shows that taking collagen peptides 7.5 grams twice daily for 12 weeks increases running distance by approximately 1,034 meters, compared with an increase of 703 meters in those taking placebo, although there was no effect on speed (104641). A clinical study in healthy young male athletes undergoing heavy strength and power training shows that taking collagen peptides 20 grams and vitamin C 50 mg daily for 3 weeks improves squat performance and countermovement jump performance when compared with placebo. However, removal of a single outlier negated the statistical significance of most of these findings (107456). Also, it is unclear if any improvements from this study are due to collagen peptides, vitamin C, or the combination.
Atopic dermatitis (eczema). It is unclear if oral or topical collagen peptides are beneficial for improving the severity of eczema. Details: A small clinical study in patients with atopic dermatitis shows that taking a porcine skin-derived collagen peptide with a high ratio of tripeptides with glycine-X-Y sequences, 3.9 grams daily for 12 weeks, improves symptoms and severity of eczema when compared to baseline. There was no improvement in the group taking the same dose of porcine skin-derived collagen peptide without the high ratio of tripeptides (101605). Another very small clinical study in a mixed population of patients with atopic dermatitis and dry skin shows that twice daily application of an emollient containing collagen peptides, soluble proteoglycan, and hyaluronic acid for 4 weeks reduces itching severity from moderate at baseline to mild or almost none. Transepidermal water loss and skin hydration also improved when compared to baseline (107465). It is unclear if any improvements are due to collagen peptides, the other ingredients, or the combination. Both of these studies are limited by their small size and lack of comparator groups.
Burns. Some preliminary clinical research suggests that oral collagen peptides might reduce the time needed for burn healing. Details: In male patients with 20% to 30% body surface area burns, a small clinical trial shows that taking a collagen-based supplement providing collagen peptides (Amutiya, Qom) 36 grams daily for 4 weeks improves wound healing when compared with taking an isocaloric supplement containing the same amount of soy protein. Complete wound healing occurred in 50% and 100% of patients taking collagen for 2 and 4 weeks, respectively, compared with 7% and 40% of those taking the isocaloric product. The duration of hospital stay was not significantly different between the two groups (104642). A small clinical study in hospitalized adults with 20-45% body surface area 2nd or 3rd degree burns shows that consuming a beverage containing collagen peptides 40 grams daily for 4 weeks shortens the time to wound healing, improves scar scores, and reduces the duration of hospital stays but does not limit wound infections when compared with placebo. Adding fish oil 3 grams daily did not further improve outcomes (110667).
Brittle nails. One small clinical study suggests that oral collagen peptides may improve nail health in people with brittle nails. Details: A small clinical study shows that taking a specific porcine type I collagen peptide product (VERISOL, Gelita AG) 2.5 grams daily for 6 months improves overall symptoms of brittle nail syndrome, increases nail growth rate by 12%, and reduces broken nail frequency by 42% when compared with baseline (101606). This study was limited by its small size and lack of a comparator group.
Cellulite. One small clinical study suggests that oral collagen peptides may reduce cellulite. Details: In people with cellulite, a small clinical study shows that taking specific collagen peptides (VERISOL by Gelita AG) 2.5 grams daily for 6 months seems to reduce cellulite, skin waviness, and dermal density by a small amount when compared with placebo (101619).
Cognitive function. It is unclear if oral collagen peptides are beneficial for improving memory. Details: In healthy adults, preliminary clinical research shows that taking collagen peptides 5 grams daily for 4 weeks improves some measures of memory and verbal learning when compared to baseline (104643). This study was limited by its small size and lack of a comparator group.
Dermatoporosis. One small clinical study suggests that using oral or topical collagen peptides does not improve this condition. Details: A small clinical study in post-menopausal patients aged 70 years on average with mild dermatoporosis shows that taking collagen peptides 5 grams daily, applying a collagen peptides 2.5% serum 3 pumps nightly to each forearm, or using these in combination for 6 months does not improve skin lesions, epidermal thickness, collagen or elastin density, or patient perception of skin improvement when compared with placebo (110731). However, it is unclear if these results apply to patients with more severe dermatoporosis.
Diabetes. Some preliminary clinical research suggests that oral collagen peptides might have a small effect on glycemic indices. Details: Preliminary clinical research in patients with type 2 diabetes shows that taking fish-derived collagen peptides 6.5 grams orally twice daily for 3 months, in addition to treatment with antidiabetes drugs, may modestly reduce levels of fasting blood glucose, glycated hemoglobin, and fasting blood insulin and may increase levels of insulin sensitivity when compared with antidiabetes drugs and placebo (101626,101627).
Erythema. It is unclear if oral collagen peptides are beneficial for erythema. Details: A moderate-sized clinical study in adults with dry and wrinkled eye skin shows that taking low-molecular weight collagen peptides (GPVGPS Collagen, Daehan Chemtech) 2000 mg daily for 12 weeks reduces erythema index when compared with placebo (112458).
Exercise-induced gastrointestinal (GI) symptoms. It is unclear if oral collagen peptides prevent GI symptoms due to exercise. Details: A small crossover study in moderately well-trained young adults shows that taking collagen peptides 10 grams daily for 7 days prior to rigorous treadmill exercise does not limit GI symptoms but may attenuate some markers of GI distress when compared with placebo (110665).
Exercise-induced muscle damage. It is unclear if oral collagen peptides improve recovery from muscle damage after exercise. Details: A small clinical study in active adults shows that taking oral collagen peptides 25 grams immediately post-exercise and once daily for 3 days does not improve indices of muscle recovery including muscle soreness, muscle function, or running economy, when compared with placebo (116133).
Exercise-induced muscle soreness. It is unclear if oral collagen peptides prevent muscle soreness after exercise. Details: Preliminary clinical research in a small number of healthy, recreationally active adults shows that taking collagen peptides (Peptan, Rousselot BVBA, Collagen Peptides, Vital Proteins) 10-15 grams twice daily, starting 7 days prior to strenuous exercise and continuing for 2-5 days after, does not reduce muscle soreness when compared with placebo (100700,104648). However, there was a small benefit on the recovery of countermovement jump ability within 24 hours (104648). Furthermore, another small clinical study in adults unaccustomed to exercise shows that taking collagen peptides 10 grams daily for 33 days modestly reduces muscle soreness and fatigue immediately after the exercise load, but not 2 hours after exercise or the next morning, when compared with placebo (111639). Also, a small clinical study in active middle-aged adults shows that taking specific collagen peptides (SOLUGEL Collagen Peptides, PB Leiner) 10 grams daily for 6 months improves pain in those who exercise frequently (>188 minutes weekly) when compared with placebo. However, collagen peptides do not seem to improve pain in low frequency exercisers (<188 minutes weekly) (112455). Collagen peptides have also been evaluated in combination with other ingredients. One preliminary clinical study in healthy, recreationally active adults shows that taking a specific product (BioCell Collagen, BioCell Technology, LLC) containing collagen peptides from chicken collagen type II, hyaluronic acid, and chondroitin sulfate 1.5 grams twice daily for 6 weeks prior to two bouts of intense resistance exercise attenuates increases in biomarkers of muscle damage and decreases delayed onset muscle soreness when compared with placebo (96301). It is unclear if these benefits are due to collagen peptides, other ingredients or the combination.
Gingivitis. It is unclear if oral collagen peptides are beneficial for patients with gingivitis. Details: A small clinical study in patients with mild-to-moderate chronic gingivitis shows that taking a specific collagen peptide product (Verisol B, Gelita AG) 5 grams daily for 90 days following mechanical plaque removal reduces bleeding and inflammation but does not improve plaque scores when compared with placebo (110666).
Hypertension. Limited research suggests that oral collagen peptides may lower systolic or diastolic blood pressure. However, results are inconsistent. Details: One preliminary clinical study in patients with hypertension and type 2 diabetes shows that taking fish-derived collagen peptides 6.5 grams twice daily for 3 months modestly reduces diastolic, but not systolic, blood pressure when compared with placebo (101626). Another small clinical study in patients with mildly elevated blood pressure shows that taking a test food containing chicken leg-derived collagen peptides 2.9 grams daily for 12 weeks lowers systolic, but not diastolic, blood pressure when compared with placebo (101610). An additional small clinical study in patients with mild hypertension shows that taking chicken leg-derived collagen peptides 5.2 grams daily 4 weeks reduces systolic blood pressure by 12 mmHg when compared with baseline (101618). This study was limited by its small size and lack of a comparator group. The reasons for conflicting data are unclear.
Insomnia. It is unclear if oral collagen peptides are beneficial for insomnia. Details: A very small clinical study in physically active males with difficulty sleeping shows that taking collagen peptides 15 grams before bedtime for 7 nights reduces the frequency of nocturnal awakenings and improves cognitive accuracy but does not improve objective measures of total sleep time, latency, efficiency, stage changes, waking after sleep onset, other cognitive function measures, or subjective measures of sleepiness, fatigue, and sleep quality when compared with placebo (112459).
Joint pain. Most research shows that oral collagen peptides might moderately reduce joint pain in young athletes. However, evidence in other adults is conflicting. Details: Preliminary clinical research in student athletes with joint pain shows that taking a specific collagen peptide product (FORTIGEL, Gelita AG) 10 grams in 25 mL of liquid daily for 24 weeks modestly improves pain during movement and at rest when compared with placebo (101601). Other clinical research in young adults exercising or participating in sports at least 3 hours weekly with activity-related knee pain shows that taking this same product 5 grams daily for 12 weeks reduces pain intensity during activity by 38% to 41%, compared with a 26% to 28% reduction in those taking placebo. However, there was no improvement in pain at rest or after the activity when compared with placebo (97623,107454). Furthermore, it is not clear if these effects are clinically significant. Research on the use of collagen peptides in older patients is conflicting. A large clinical study in generally healthy adults with functional knee and hip pain during daily activities shows that taking a specific collagen peptide product (FORTIGEL, Gelita AG) 5 grams daily for 12 weeks modestly reduces pain at rest and during walking, per a physician assessment, when compared with placebo (114907). The validity of this finding is limited by the use of per-protocol analysis. A small clinical study in otherwise healthy patients aged 40-65 years with joint discomfort shows that taking a specific collagen peptides product (AVC-H2, Avicenna) 1.25 grams twice daily for 8 weeks improves overall Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores by 37% at 4 weeks, compared with 14% in those receiving placebo. However, this difference in improvement was no longer significant at 8 weeks. Collagen peptides also improved the physical activity and stiffness subdomains, but not the pain subdomain, at 4 and 8 weeks when compared with placebo (107455). A larger clinical study in patients 50 years or older with general joint pain shows that taking a specific collagen peptides product (Genacol) 1200 mg daily for 6 months does not reduce pain or improve function when compared with placebo (97657). However, collagen peptides used in combination with other ingredients have shown benefit. Preliminary clinical research in patients 51-70 years of age shows that taking a specific combination product (Gold Collagen Active, Minerva Research Labs) containing fish collagen peptides 4 grams, glucosamine hydrochloride 1000 mg, chondroitin sulfate 500 mg, L-carnitine 200 mg, and other ingredients daily for 90 days reduces joint pain by 43% when compared with baseline, while patients taking placebo saw negligible improvement in pain. A greater percentage of patients taking this product also perceived improvements in joint discomfort, flexibility, mobility, and rigidity when compared with placebo (100703). It is unclear if these effects are due to collagen peptides, other ingredients, or the combination.
Knee pain. Collagen peptides have only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with mild to moderate meniscal tears shows that taking a combination product containing collagen peptides 2000 mg, hydrolyzed collagen type II, chondroitin sulfate, glucosamine sulfate, hyaluronic acid, methylsulfonylmethane, and other ingredients (Naturagen 4 Joint, Naturagen) daily for 8 weeks improves some assessments of pain and function but does not improve objective measures, including leg strength, balance, or stair climbing time, when compared with placebo (116134). It is unclear if these effects are due to collagen peptides, other ingredients, or the combination.
Obesity. It is unclear if oral collagen peptides are beneficial for weight loss. Details: A preliminary clinical study in adults with overweight shows that taking skate skin-derived collagen peptides 2 grams daily for 12 weeks modestly reduces body fat mass by 1.2 kg, compared with an increase of 0.3 kg in the placebo group (101621). It is unclear if collagen peptides improve weight loss or reduce body fat mass in the long-term.
Osteoarthritis. Most research suggests that oral collagen peptides improve pain in patients with knee osteoarthritis; however, any improvement is modest and may not be considered clinically significant. Details: A meta-analysis of 3 clinical studies, all of which are included below, in adults with knee osteoarthritis shows that taking collagen peptides or hydrolyzed collagen reduces pain when compared with placebo (112456). Clinical research shows that taking specific collagen peptides (Colnatur, Protein SA) 10 grams daily for 5 months increases the number of patients who experience at least a 30% improvement in pain by approximately 42% when compared with placebo. However, there is no difference between groups when the Western Ontario and McMaster Universities (WOMAC) scale is used. Patients with the greatest joint deterioration at baseline, as well as those with the lowest dietary meat intake, seemed most likely to experience benefit from collagen peptides (97635). Another small clinical study shows that taking collagen peptides isolated from pork skin and bovine bone (Nitta Gelatin Inc.) 5 grams dissolved in 250 mL water or milk twice daily after food for 13 weeks modestly improves pain when compared with placebo (101611). Another small clinical study in patients over 40 years old shows that taking collagen peptides (Colatech) 10 grams daily for 90 days reduces pain by about 2 points on a 100-point scale, compared with a 0.9-point reduction with glucosamine sulfate 1.5 grams. Ibuprofen use was not affected (101622). One multicenter clinical study shows that taking collagen peptides 10 grams daily for 6 months does not relieve pain or improve joint function when compared with placebo, although a trend towards reduced pain and improved joint function was observed in patients with severe symptoms at baseline (7704). Collagen peptides have also been evaluated in combination with other ingredients. Clinical research in patients with osteoarthritis of the knee, hip, or hand shows that taking a specific product (BioCell Collagen, BioCell Technology, LLC) containing collagen peptides from chicken collagen type II, hyaluronic acid, and chondroitin sulfate 1 gram twice daily for up to 10 weeks reduces pain and the need for rescue analgesics and increases physical activity when compared with placebo (28678,28680). Similarly, a moderate-size clinical study in patients aged 45-75 years with mild to moderate knee osteoarthritis undergoing resistance exercise twice weekly shows that taking a specific product (Suntory Beverage and Food Asia) containing collagen peptides from chicken collagen type II, hyaluronic acid, and chondroitin sulfate 2 grams daily for 24 weeks does not improve WOMAC scores when compared with glucosamine 1.5 grams daily or placebo, but may modestly improve pain scores when compared with placebo. However, the use of rescue analgesics was not assessed. Adding essence of chicken 5.81 grams daily to collagen peptides did not improve WOMAC or pain scores (110670). Also, preliminary clinical research in patients with knee osteoarthrosis shows that taking a specific product (Ialoral 1500, PharmaSuisse Laboratories Srl) containing collagen peptides, chondroitin sulfate, hyaluronic acid, and keratin peptides for 4 weeks improves pain and function by a moderate amount when compared with baseline (104645). However, the validity of these findings is limited by the lack of statistical comparison to the control group. It is unclear if these effects are due to collagen peptides, other ingredients, or the combination.
Osteopenia. It is unclear if oral collagen peptides prevent loss of bone mineral density (BMD) in postmenopausal adults. Details: A large clinical study in patients with reduced BMD after menopause shows that taking specific collagen peptides (Fortibone, Gelita AG) 5 grams daily for 12 months increases BMD of the spine and the femoral neck by 3% and 7%, respectively, compared with losses of 1% with placebo (101609). In a very small observational extension of this study, BMD continued to increase over an additional 4 years when compared with baseline. However, the validity of these findings is limited by the lack of a comparator group (107340). Collagen peptides have also been evaluated in combination with calcium and vitamin D. In patients with osteopenia after menopause, a small clinical study shows that taking collagen peptides calcium chelate 5 grams, containing elemental calcium 500 mg and vitamin D3 200 IU, daily for 12 months does not affect total hip, total body, or vertebral BMD when compared with calcium 500 mg and vitamin D 200 IU (101604). The validity of these results is limited by a high dropout rate and insufficient power to detect smaller effects. Conversely, another small study in this population shows that taking specific collagen peptides (Fortibone, Gelita AG) in combination with elemental calcium (as calcium lactate) 500 mg and vitamin D3 400 IU daily for 12 months improves trabecular bone mineral content, trabecular volumetric BMD, and cortical volumetric BMD, but not cortical bone mineral content, when compared with a combination tablet containing equivalent doses of elemental calcium (as calcium carbonate) and vitamin D (107453). It is unclear if these effects are due to collagen peptides, other ingredients, or the combination.
Osteoporosis. It is unclear if oral collagen peptides improve bone mineral density (BMD) in adults with osteoporosis after menopause. Details: In patients with osteoporosis after menopause, clinical research shows that taking collagen peptides 10 grams daily in addition to twice weekly intramuscular calcitonin for 6 months does not improve BMD in the forearm when compared with calcitonin alone (104649). It is unclear if supplementation with collagen peptides improves BMD in the femoral neck or lumbar spine.
Pressure ulcers. Oral collagen peptides might help to improve ulcer size and healing. Details: A small clinical study in patients with Stage II, III, or IV pressure ulcers shows that taking collagen peptides 5 grams orally three times daily for 8 weeks in addition to standard care improves ulcer size and exudate when compared with placebo and standard care (101612). This study was limited because it only used one scale to assess healing of the pressure ulcer. Another small clinical study in patients with stage II or III pressure ulcers shows that receiving standard care and collagen peptides with high levels of prolyl-hydroxyproline 5 grams twice daily for 16 weeks improves ulcer exudate, healing, and wound size when compared with standard care plus placebo (101620).
Sarcopenia. Oral collagen peptides might help to increase fat-free mass. However, it is unclear if collagen peptides are more beneficial than other types of protein. Details: A small clinical study in elderly males with sarcopenia shows that taking collagen peptides from type I collagen 15 grams daily for 12 weeks along with three resistance training sessions weekly modestly increases fat-free mass and power when compared with resistance training and placebo (101624). It is unclear if supplementation with collagen peptides is more beneficial than supplementation with protein.
Sprains. It is unclear if oral collagen peptides improve ankle instability after a previous sprain. Details: A small clinical study in athletes with chronic ankle instability from an ankle sprain shows that taking collagen peptides 5 grams daily for 6 months improves subjective ankle instability when compared with placebo. However, ankle stiffness, which is a more objective measure of ankle instability, is not improved when compared with placebo (101603).
Tendinopathy. It is unclear if oral collagen peptides improve tendon pain. Details: A small clinical study in patients with Achilles tendinopathy shows that taking a specific collagen peptides supplement (TENDOFORTE, Gelita AG) 2.5 grams daily for 3 months in addition to a calf-strengthening program improves pain when compared with baseline (101615). The validity of this finding is limited by the lack of a comparator group.
Wound healing. It is unclear if oral collagen peptides improve wound healing. Details: A small clinical study in healthy volunteers with wounds after photothermolysis shows that taking collagen peptides 3 grams daily for 4 weeks improves erythema, skin hydration, and skin elasticity when compared with placebo (101599). This study was limited by small size, short duration, and no direct measurement of wound healing or scar formation.
Wrinkled skin. Some small clinical studies suggest that oral collagen peptides might help to reduce lines and wrinkles from sun damage. Details: Preliminary clinical research in females with photodamaged skin shows that taking a specific low molecular weight collagen peptide product (Evercollagen, Newtree Co.) 1000 mg daily for 12 weeks modestly improves most measures of skin wrinkling, hydration, and elasticity when compared with placebo. This specific collagen peptide product is standardized to contain more than 15% glycine-containing tripeptides, including 3% glycyl-prolyl-hydroxyproline (100702). Another moderate-sized clinical study in adults with dry and wrinkled eye skin shows that taking low-molecular weight collagen peptides (GPVGPS Collagen, Daehan Chemtech) 2000 mg daily for 12 weeks reduces skin wrinkling parameters including facial skin roughness, peak-to-valley values, maximum wrinkle height, and eye wrinkle volume and improves skin hydration and skin elasticity when compared with placebo. However, there was no improvement in maximum wrinkle depth (112458). Another preliminary clinical study shows that taking a specific combination product (BioCell Collagen, BioCell Technology, LLC) containing collagen peptides from chicken collagen type II 600 mg, low molecular weight hyaluronic acid 100 mg, and chondroitin sulfate 200 mg daily for 12 weeks reduces lines and wrinkles associated with both natural aging and photoaging by about 13% when compared to baseline (28681). This study was limited by the lack of a comparator group. Additionally, it is unclear if these effects are due to collagen peptides, other ingredients, or the combination. More evidence is needed to rate collagen peptides for these uses.

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Below is general information about the safety of the known ingredients contained in the product GALT-immune. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETA-GLUCANS (Beta Glucans)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Beta-glucans derived from oat bran, baker's yeast, or brewer's yeast (Saccharomyces cerevisiae) have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately, short-term in medicinal amounts. There is some evidence that yeast-derived beta-glucans 15 grams daily can be used safely for up to 8 weeks (7272). Oat-derived beta-glucans 3-10 grams daily can also be used safely for up to 12 weeks (7272,5796,17129,34700,34727,34729,34765,34766,34811,34812)(34876,107935,109206). ...when used topically and appropriately. A specific beta-glucans serum and emulsion (Awake; Hangzhou Songyang Biotechnical) combination has been used with apparent safely for up to 12 weeks in clinical research (109210). A specific beta-glucans cream (Imunoglukan P4H, PLEURAN s.r.o.) has been used with apparent safety 2-3 times daily for up to 6 months (98201).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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BOVINE COLOSTRUM (Colostrum)

LIKELY SAFE ...when used orally and appropriately. There are no reports of significant toxicity in multiple human trials (4901,4903,4904,4905,4906,4907,4908,4909,36980,36988) (36992,36995,36998,37000,92412,92413,92415,101799,111136,111138) (111139,114817). However, bovine colostrum is derived from animals, and there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated bovine colostrum.

POSSIBLY SAFE ...when used rectally and appropriately, short-term. Bovine colostrum has been used with apparent safety when administered as a 10% enema twice weekly for up to 4 weeks (9730). ...when used intravaginally and appropriately, short-term. Bovine colostrum has been used with apparent safety when administered vaginally as a tablet twice weekly for up to 6 months, as a 1% cream once daily for up to 15 days, or as a gel containing 2.3% bovine colostrum daily for 12 weeks (92424,98819,101794). There is insufficient reliable information available about the safety of bovine colostrum when used topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Bovine colostrum has been used with apparent safety in children for 1-3 months (92420,95924,101797,114819). There is insufficient reliable information available about the safety of long-term use of bovine colostrum in children.

CHILDREN: POSSIBLY UNSAFE
when used enterally in very preterm infants in the first few weeks of life. Enterally, bovine colostrum added to breastmilk for very preterm infant feeding in the first 14 days of life has been associated with a higher rate of periventricular leukomalacia when compared with preterm formula added to breastmilk in one clinical trial (114816). Orally, the addition of bovine colostrum to breastmilk for very preterm infant feeding resulted in infants requiring more calcium and phosphate supplementation to maintain acceptable blood levels when compared with conventional fortifier in one clinical trial (114822).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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COLLAGEN PEPTIDES (hydrolyzed Fish Collagen)

POSSIBLY SAFE ...when used orally and appropriately, short-term. Collagen peptides have been used with apparent safety at doses up to 10 grams daily for up to 6 months and in doses up to 40 grams daily for up to 4 weeks (97632,97635,101615,101621,104638,104643,104644,104647,101622,110667)(114907,115044). PREGNANCY &

LACTATION:
Insufficient reliable information available; avoid using.

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Adverse Effects view details

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Below is general information about the adverse effects of the known ingredients contained in the product GALT-immune. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETA-GLUCANS (Beta Glucans)

General ...Orally and topically, beta-glucans seem to be well-tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis, skin reactions.

Dermatologic ...Topically, a specific beta-glucans cream r.o.) has been reported to cause skin reactions and contact dermatitis in one clinical trial. These reactions occurred in 27% of patients; reactions were mild and self-limiting in 12% of patients (98201).

Hematologic ...In one clinical trial of children and young adults with neuroblastoma, one of 44 patients developed transient elevations of aspartate transaminase and alanine transaminase within five days of starting oral beta-glucans 120 mg/kg daily (109203).

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BOVINE COLOSTRUM (Colostrum)

General ...Orally, bovine colostrum is well tolerated.

Endocrine ...Enterally, the addition of bovine colostrum to breastmilk for very preterm infant feeding resulted in infants requiring more calcium and phosphate supplementation to maintain acceptable blood levels when compared with conventional fortifier in one clinical trial (114822).

Gastrointestinal ...Orally, bovine colostrum has caused nausea and vomiting in an individual with HIV-related cryptosporidiosis (4905). In clinical trials of bovine colostrum, bloating, nausea, diarrhea, and unsettled stomach have been reported as mild in nature by a few patients (92414,101792) with a similar rate of occurrence as those taking a whey-based control (114819).

Hematologic ...Orally, bovine colostrum has caused decreased serum hematocrit in HIV patients treated for infectious diarrhea (4905).

Hepatic ...Orally, bovine colostrum has caused elevated liver function tests in HIV patients treated for infectious diarrhea (4905).

Immunologic ...Topically, there is a case report of anaphylaxis, urticaria, and itching related to bovine colostrum (101793).

Neurologic/CNS ...Enterally , bovine colostrum has been associated with increased risk of periventricular leukomalacia in very preterm infants. Specifically, in a large, multi-center, clinical study conducted in 7 neonatal intensive care units in China, 5 cases of periventricular leukomalacia (PVL), diagnosed with magnetic resonance imaging, were reported among the 155 infants fed bovine colostrum supplemented breastmilk until postnatal day 14, while no cases were reported among the 181 infants receiving preterm formula supplemented breastmilk. Three of the 5 infants with PVL were fed small volumes of bovine colostrum (less than 10 mL/kg daily) while 2 were fed larger volumes of bovine colostrum (18-35 mL/kg daily). in addition to preterm formula (114816).

Renal ...Enterally, bovine colostrum added to breastmilk for infant feeding until postnatal day 14 among very preterm infants has been associated with higher blood urea nitrogen levels by about 3 mg/dL when compared with preterm formula added to breastmilk (114816).

Other ...Theoretical adverse effects to bovine colostrum include an allergic reaction in individuals allergic to bovine milk products. There is also some concern that bovine colostrum that is obtained from cows in countries where bovine spongiform encephalitis (BSE) has been reported might be unsafe, however, there is no research indicating that colostrum can be contaminated with the BSE-causing prion. Countries where BSE has been reported include Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland, Switzerland, Oman, and Belgium (1825). Until more is known, tell patients to avoid these products unless country of origin can be determined. Patients should avoid products that are produced in countries where BSE has been found.

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COLLAGEN PEPTIDES (hydrolyzed Fish Collagen)

General ...Orally, collagen peptides seem to be well tolerated.

Dermatologic ...Orally, a case of a mild skin rash has been reported for a patient who used a specific collagen peptide-containing product (BioCell Collagen) (28680).

Gastrointestinal ...Orally, collagen peptides may cause nausea, dyspepsia, diarrhea, and flatulence, but these adverse effects are rare (101622,104639).

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GALT-immune by Energetix

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