Probiotic Gummies Strawberry by Mary Ruth's

POSSIBLY EFFECTIVE

• Antibiotic-associated diarrhea. Oral Bacillus subtilis seems to be beneficial for preventing antibiotic-associated diarrhea. Details: Clinical research in patients given antibiotics for at least 5 days shows that taking a total of 2 billion colony-forming units (CFUs) of B. subtilis B2335 alone or with Bacillus licheniformis B2336 twice daily results in around 8% or 10% of patients, respectively, developing antibiotic-associated diarrhea compared with around 32% of those taking placebo. In order to prevent antibiotic-associated diarrhea, four patients need to be treated with Bacillus subtilis. Nausea, vomiting, abdominal pain, and bloating were also prevented. The probiotics were started one day prior to antibiotic treatment and continued for 7 days after completion (110854).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Small clinical studies suggest that oral Bacillus subtilis may not improve athletic performance. Details: Two small clinical trials in offseason college athletes undergoing a resistance training program show that taking B. subtilis DE111 (Deerland Enzymes, Kennesaw, GA, USA) does not improve measures of athletic performance, including speed, strength, or agility, when compared with placebo (110850,110855). In one trial, female athletes took B. subtilis DE111 5 billion colony forming units (CFUs) daily for 10 weeks (110850). In the other, male athletes took one billion CFUs daily for 12 weeks (110855). Larger clinical trials in these and other athletic populations are still needed.
• Atopic dermatitis (eczema). Although there has been interest in using oral Bacillus subtilis for atopic dermatitis, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Cirrhosis. Although there has been interest in using oral Bacillus subtilis for cirrhosis, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Clostridioides difficile infection. Although there has been interest in using oral Bacillus subtilis for C. difficile prevention and treatment, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Constipation. Although there has been interest in using oral Bacillus subtilis for preventing constipation in infants, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Critical illness (trauma). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in critically ill adults receiving ventilation shows that receiving B. subtilis and Enterococcus faecalis (Medilac-S) three times daily through a nasogastric feeding tube for up to 14 days results in microbiologically confirmed VAP in around 36% of individuals compared with around 50% of patients not receiving these probiotics, and the mean time to develop VAP was increased by almost 3 days. These findings suggest that seven patients need to be treated to prevent one episode of VAP. However, there was no effect on the incidence of clinically suspected VAP or length of hospital stay. All patients were also given standard preventive strategies (110851).
• Diabetes. Although there has been interest in using oral Bacillus subtilis for diabetes, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Diarrhea. It is unclear if oral Bacillus subtilis is beneficial for patients with chronic loose stools. Details: A small clinical study in adults with chronic loose stools shows that taking B. subtilis C-3102 2.2 billion colony-forming units (CFUs) daily for 8 weeks modestly decreases stool frequency and improves stool form when compared with placebo. There was no difference in stool water content or other gastrointestinal symptoms (110836). The effect of B. subtilis on symptoms of chronic diarrhea is unclear from this study.
• Dyslipidemia. Although there has been interest in using oral Bacillus subtilis for dyslipidemia, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Dyspepsia. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some studies have used B. subtilis in combination with other probiotics. In adults with functional dyspepsia, a small clinical study shows that taking a combination of B. subtilis MY02 and Bacillus coagulans MY01 as 1.25 billion colony-forming units (CFUs) each twice daily for 8 weeks improves postprandial distress scores of at least 0.7 in 48% of patients, compared with only 20% of those taking placebo (107611). Also, a small study in adults with non-specific gastrointestinal discomfort shows that taking a specific combination supplement (SNZ TriBac, Sanzyme Biologics) containing B. subtilis SNZ 1972, Bacillus coagulans SNZ 1969, and Bacillus clausii SNZ 1971, 2 billion CFUs daily for 30 days, decreases self-reported symptoms of burping, belching, and sour taste when compared with placebo. However, there was no effect on symptoms such as heartburn, nausea, and passing gas (104231). It is unclear if these effects are due to B. subtilis, other ingredients, or the combinations.
• Flatulence. It is unclear if oral Bacillus subtilis is beneficial for patients with flatulence. Details: A small clinical study in healthy adult shows that taking B. subtilis BS50 2 billion colony-forming units (CFUs) once daily for 6 weeks does not affect the proportion of patients with flatulence when compared with placebo. However, the proportion of patients with an improvement in burping and bloating was more than doubled when compared with placebo (110841).
• Helicobacter pylori. Although there has been interest in using oral Bacillus subtilis for Helicobacter pylori infection, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Hypertension. Although there has been interest in using oral Bacillus subtilis for hypertension, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Irritable bowel syndrome (IBS). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in patients with IBS with diarrhea shows that taking B. subtilis 100 million colony-forming units (CFUs), along with Streptococcus faecium 900 million CFUs and tianeptine 37.5 mg three times daily, improves overall IBS symptoms to the same degree as taking the same doses of B. subtilis and Streptococcus faecium in combination with amitriptyline 10 mg daily for 4 weeks (100805). The same dose of B. subtilis was used by all patients; the effect of B. subtilis alone is unclear.
• Necrotizing enterocolitis (NEC). Although there has been interest in using oral Bacillus subtilis for preventing NEC in infants, there is insufficient reliable information about the clinical or adverse effects of B. subtilis for this purpose.
• Neonatal jaundice. Although there has been interest in using oral Bacillus subtilis for preventing neonatal jaundice, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Pancreatitis. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients hospitalized with mild acute pancreatitis shows that taking a combination of B. subtilis and Enterococcus faecium reduces hospital length of stay by approximately 0.7 days when compared with taking placebo. There were also modest reductions in time to relief of abdominal symptoms and time to oral feeding (110849). The dose of B. subtilis is unclear from this study. Also, it is unclear if these effects are due to B. subtilis, Enterococcus faecium, or the combination.
• Prematurity. Oral or parenteral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in premature infants shows that receiving B. subtilis, along with Enterococcus faecium and multivitamins (Medilac-Vita) twice daily with mosapride 0.5 mg three times daily modestly increases the decline in serum levels of total bilirubin and the fading of jaundice compared with mosapride in combination with Saccharomyces boulardii or routine care only. Growth rate, symptoms of abdominal discomfort, gastrointestinal motility, rates of feeding intolerance, and incidence rates of complications such as sepsis and necrotizing enterocolitis, were all improved in the groups receiving mosapride and probiotics compared with routine care only (110852). The dose of B. subtilis is unclear from this study. Also, it is unclear if these effects are due to B. subtilis, other ingredients, or the combinations.
• Sepsis. Although there has been interest in using oral Bacillus subtilis for preventing sepsis in infants, there is insufficient reliable information about the clinical effects of B. subtilis for this purpose.
• Ulcerative colitis. Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of over 50 clinical studies in patients with ulcerative colitis shows that taking a specific product containing B. subtilis R0179 and Enterococcus faecium R0026 (Medilac-S), 3 billion colony-forming units (CFUs) daily of for 4-96 weeks, as adjunctive therapy with oral aminosalicylates, usually sulfasalazine or mesalazine, increases the likelihood of inducing clinical remission by 21% when compared with the conventional therapy alone. The proportion of patients reporting symptoms such as abdominal pain and diarrhea was reduced by 40% to 53%. Most individual studies showed that these probiotics reduced the likelihood of symptom recurrence; however, a pooled analysis for this outcome could not be conducted (110853). It is unclear if any effects are due to B. subtilis, Enterococcus faecium, or the combination.
• Ventilator-associated pneumonia (VAP). Oral Bacillus subtilis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in critically ill adults receiving ventilation shows that receiving B. subtilis and Enterococcus faecalis (Medilac-S) three times daily through a nasogastric feeding tube for up to 14 days results in microbiologically confirmed VAP in around 36% of individuals compared with around 50% of patients not receiving these probiotics, and the mean time to develop VAP was increased by almost 3 days. These findings suggest that seven patients need to be treated to prevent one episode of VAP. However, there was no effect on the incidence of clinically suspected VAP or length of hospital stay. All patients were also given standard preventive strategies (110851). More evidence is needed to rate Bacillus subtilis for these uses.

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LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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POSSIBLY SAFE ...when taken orally and appropriately. Some strains of B. subtilis are considered "generally regarded as safe" (GRAS) for use in food (110841). Bacillus subtilis has been used with apparent safety in clinical studies. B. subtilis strains BS50, B2335, CU1, MB40, MY02, or R0179 have been used with apparent safety in doses of 2-10 billion colony forming units (CFUs) daily for 2-8 weeks (107611,110841,110843,110846,110847,110848,110854,110859). One specific product, B. subtilis DE111, has been used with apparent safety in doses of one billion CFUs daily for 12 weeks or 5 billion CFUs daily for 10 weeks (110850). Another specific product (Medilac-S), containing a combination of B. subtilis R0179 and Enterococcus faecalis, has been used with apparent safety in doses providing up to 300 million CFUs of B. subtilis daily for up to 96 weeks (110853,110860).

CHILDREN:
There is insufficient reliable information available about the safety of Bacillus subtilis in children of any age. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

PREGNANCY AND LACTATION:
Insufficient reliable information available when used in doses higher than those found in foods; avoid using.

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LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking Bacillus subtilis with antibiotic drugs might decrease the effectiveness of B. subtilis.  Details Since B. subtilis preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and B. subtilis preparations by at least 2 hours.

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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General ...Orally, Bacillus subtilis seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. subtilis may cause bacteremia in certain patients.

Dermatologic ...Orally, itching and redness were reported rarely (110848).

Gastrointestinal ...Orally, diarrhea has been reported rarely (110846).

Immunologic ...There are cases of Bacillus subtilis var. natto bacteremia and meningitis in patients with frequent consumption of natto, soybeans fermented with B. subtilis var. natto (110844,110862). A 70-year-old female recovered from bacteremia after this consumption was stopped and she was treated with vancomycin. It was hypothesized that this infection was due to an immunocompromised state related to age, type 2 diabetes, kidney failure, multiple myeloma, coronavirus disease 2019 (COVID-19), and treatment with immunosuppressive therapy (110844). In a 67-year-old female, bacterial entry was suspected to be related to erosion of her esophagus (110862).
There have been other rare cases of bacteremia or infections due to B. subtilis. These cases are unlikely to be related to intake or supplementation but to an immunocompromised state and/or introduction of bacteria to the body via non-oral routes. Cases of bacteremia include a newborn infant with sepsis, an adult with esophageal perforation, and a patient undergoing bone marrow transplantation subjected to contaminated materials (110834,110837,110840). There is also a case of cholangitis in a 15-year-old child with a recent kidney transplant related to polycystic kidney disease (110838).

Neurologic/CNS ...Orally, one case of headache was reported in a clinical trial (110847).

Pulmonary/Respiratory ...Orally, two cases of nasal obstruction were reported in a clinical trial (110847).

Other ...Orally, an acute episode of mild pain was reported in a clinical trial (110847).

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General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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