Tegricel Colostrum by Designs for Health

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).
• 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). 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 is effective for improving growth and bowel habits in 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).
• 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 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.
• 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. Although there has been interest in using oral bovine colostrum for wound healing, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose. More evidence is needed to rate bovine colostrum for these uses.

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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). 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). There is insufficient reliable information available about the safety of long-term use of bovine colostrum in children.

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

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

Gastrointestinal ...Orally, bovine colostrum has caused nausea and vomiting in an individual with HIV-related cryptosporidiosis (4905). Bloating, nausea, diarrhea, and unsettled stomach have been reported as mild in nature by a few patients in clinical trials of bovine colostrum (92414,101792).

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).

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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