Bentonite Clay (Oral)

Evidence Level
Limited
7 Clinical Trials
7 Documented Benefits
2/5 Evidence Score

Bentonite clay is a natural clay sold as a powder or liquid to swallow, often marketed for detox and digestion. The human research is narrow and comes almost entirely from refined calcium montmorillonite clays (NovaSil and related forms) tested in people with high dietary exposure to aflatoxin, a mold toxin found in poorly stored grain. In placebo-controlled trials in Ghana, Texas and Kenya, 1.5 to 3 g a day lowered blood or urine markers of aflatoxin exposure in most comparisons, with side effects at placebo rates for up to 3 months. These results do not show a general detox effect, and they may not apply to retail bentonite, whose source and purity vary. In 2016 the FDA told consumers not to use two bentonite clay products after its labs found elevated lead, and a Dutch survey estimated that typical use of some health clays would exceed lead or arsenic limits. Purified clays such as diosmectite are sold as medicines in France.

Studied Dose 1.5 or 3 g/day of refined calcium montmorillonite in capsules for 2 weeks to 3 months; 3 g/day stirred into water for 7 days; 0.75 or 1.5 g/day for 14 days in children. Medicinal beidellitic montmorillonite: 3 g three times daily for 8 weeks.
Active Compound Bentonite clay. The human trials used refined calcium montmorillonite clay (NovaSil, Uniform Particle Size NovaSil and ACCS100); medicinal clays include diosmectite and beidellitic montmorillonite, an aluminum and magnesium silicate.

Benefits

Aflatoxin exposure markers with refined research clays (NovaSil, ACCS100)

In a 3-month placebo-controlled trial in 177 Ghanaian adults with high dietary aflatoxin exposure, capsules of refined calcium montmorillonite (1.5 or 3 g a day) lowered a blood aflatoxin marker at 3 months but not at 1 month; a urine marker fell up to 58% only with 3 g. In 234 Texas adults, only the 1.5 g dose lowered the blood marker significantly. These are exposure markers, not health outcomes.

Research clay (ACCS100) stirred into water in a 7-day crossover test

In a double-blind crossover trial in 50 adults in a Kenyan area with recurring aflatoxin outbreaks, 3 g a day of refined calcium montmorillonite stirred into water for 7 days roughly halved a urine aflatoxin marker compared with a calcium carbonate placebo. Ratings of taste and texture and reported side effects did not differ. A clay company supplied the product.

Urine marker of a second grain toxin, fumonisin B1, with research clay

In urine samples from weeks 8 and 10 of the Ghana trial, 56% of 186 samples had detectable fumonisin B1, another mold toxin found in grain. The median level was more than 90% lower with 3 g a day of the refined clay than with placebo. In rats given one dose, the drop was 20% at 24 hours and 50% at 48 hours. Like the aflatoxin results, this is an exposure marker, not a health outcome.

Blood vitamins and minerals during three months of use

A concern with any clay binder is that it may also take up nutrients. In the 177-person Ghana trial, serum vitamins A and E and 15 nutrient minerals did not differ between 3 g a day of refined clay and placebo after 3 months, but serum strontium was higher on clay. Retail bentonite taken at larger or unmeasured doses has not been tested this way.

Tolerance of refined clay in short trials in adults and children

In 50 healthy adults taking 1.5 or 3 g a day for 2 weeks, mild abdominal pain, bloating, gas, constipation or diarrhea each occurred in 2 to 8%, with no difference between doses and no changes in blood tests. Over 3 months in Ghana, side effects were as common as on placebo. Children given 0.75 or 1.5 g a day for 14 days had no adverse events attributed to the clay.

Purified smectite clays sold as medicines in some countries

Diosmectite, a purified clay, is a medicine in France. A Cochrane review of 18 trials in 2,616 children with acute infectious diarrhea found that smectite may shorten episodes by about a day when given with rehydration, with low-certainty evidence. France now advises against it under age 2 because of possible lead traces. This is medical use, not a basis for self-treatment.

Abdominal discomfort in a 524-patient trial of a medicinal clay

In an 8-week placebo-controlled trial of beidellitic montmorillonite (3 g three times daily) in 524 adults with IBS, the main pain or discomfort endpoint did not differ from placebo overall (51.7% vs 45.2% improved). The constipation-predominant subgroup did better on clay (49.4% vs 31.5%), and stool frequency did not change. This is a medicine studied in patients.

Mechanism of action

1

Binds certain toxins inside the digestive tract

According to a review by the group that developed it, the refined clay used in the human trials binds aflatoxins in the gut and lowers how much is absorbed, based largely on animal studies. The human trials measured this only indirectly, as lower toxin markers in blood and urine, so binding of other substances cannot be assumed.

2

Clay can carry and release its own elements

Clays dug from the ground can contain naturally occurring heavy metals such as lead. Across 63 clays for oral use sold in the Netherlands, the highest levels found were 99.7 mg/kg lead and 45.1 mg/kg arsenic. In the Ghana trial, serum strontium rose on clay. How much of a contaminant is released in the gut differs between clays and was estimated, not measured, in the survey.

3

Large amounts can bind electrolytes and bulk in the bowel

Doctors reporting a 3-year-old with dangerously low potassium after a colloidal bentonite home remedy was given by mouth and rectally for constipation noted that large amounts of clay can bind essential electrolytes in the gut and may cause obstruction; they suggested the rectal use may explain the case. The trial doses of 1.5 to 3 g a day did not change blood electrolytes.

Clinical trials

1
Refined Calcium Montmorillonite Safety in Healthy Adults: 2-Week Phase I RCT
PubMed

Randomized, double-blind phase I trial comparing two doses of NovaSil clay capsules, with no placebo arm, to set doses for longer studies. (Wang et al. 2005, Food Addit Contam)

50 healthy adults aged 20 to 45 (23 men, 27 women) taking 1.5 or 3 g/day as nine capsules a day for 2 weeks.

All participants finished, with 99.1% compliance. Mild digestive effects were abdominal pain (6%), bloating (4%), constipation (2%), diarrhea (2%) and gas (8%), with no difference between doses. Blood counts, liver and kidney tests, electrolytes, vitamins A and E and minerals did not change significantly in either group. Without a placebo arm, the trial shows tolerance, not benefit.

2
NovaSil Clay in Ghanaian Adults: 3-Month Placebo-Controlled Phase IIa Trial, Clinical Outcomes
PubMed

Double-blind, placebo-controlled phase IIa trial of NovaSil clay capsules testing safety and tolerance in a population with high dietary aflatoxin exposure. (Afriyie-Gyawu et al. 2008, Food Addit Contam Part A Chem Anal Control Expo Risk Assess)

177 Ghanaian adults screened from 507 volunteers, randomized to 3 g/day, 1.5 g/day or placebo for 3 months; 162 completed.

Compliance was over 97%. About 99.5% of person-time had no reported side effects; mild to moderate events (nausea, diarrhea, heartburn, dizziness) were statistically similar in all three groups. Blood counts, liver and kidney function and electrolytes did not differ between groups.

3
NovaSil Clay in Ghanaian Adults: Aflatoxin Exposure Markers in Blood and Urine
PubMed

Biomarker results from the same double-blind, placebo-controlled 3-month phase IIa trial, with clay given in capsules before meals. (Wang et al. 2008, Food Addit Contam Part A Chem Anal Control Expo Risk Assess)

Participants of the 177-person Ghana trial (3 g/day, 1.5 g/day or placebo); 656 blood and 624 urine samples analyzed.

At baseline and 1 month, the blood aflatoxin-albumin marker and the urine aflatoxin M1 marker did not differ between groups. At 3 months, the blood marker was significantly lower with both doses than with placebo, and median urine aflatoxin M1 was up to 58% lower with 3 g/day only. These are exposure markers, not measures of health outcomes.

4
NovaSil Clay and Serum Vitamins and Minerals: 3-Month Placebo-Controlled Trial
PubMed

Analysis of serum vitamins and 30 minerals from the double-blind, placebo-controlled Ghana phase IIa trial. (Afriyie-Gyawu et al. 2008, Food Addit Contam Part A Chem Anal Control Expo Risk Assess)

177 Ghanaian adults randomized to 3 g/day, 1.5 g/day or placebo for 3 months.

Serum vitamins A and E were similar across groups at baseline, 1 month and 3 months. Nutrient and non-nutrient minerals did not differ between the 3 g/day and placebo groups at 3 months, except strontium, which was significantly higher on clay. Higher or longer intakes were not tested.

5
Refined Calcium Montmorillonite (ACCS100) in South Texas Adults: 3-Month RCT
PubMed

Randomized, double-blind, placebo-controlled trial of ACCS100 for 3 months followed by 1 month without treatment. (Pollock et al. 2016, Food Addit Contam Part A Chem Anal Control Expo Risk Assess)

234 healthy men and women in Bexar and Medina counties, Texas, recruited 2012 to 2014, taking placebo, 1.5 g/day or 3 g/day.

The blood aflatoxin-lysine marker fell by month 3 in both clay groups, but the drop was statistically significant only with the lower 1.5 g dose. Adverse event rates were similar across groups, and blood chemistry and blood counts did not differ. Texas EnteroSorbents provided the clay at no cost, and the authors reported no conflicts of interest.

6
Calcium Montmorillonite in Water: 7-Day Double-Blind Crossover in Kenya
PubMed

Double-blind, randomized crossover trial of ACCS100 (3 g/day as 1 g sachets stirred into water with meals) versus calcium carbonate placebo for 7 days each, separated by a 5-day washout; the clay was supplied by Texas EnteroSorbents. (Awuor et al. 2017, Food Addit Contam Part A Chem Anal Control Expo Risk Assess)

50 healthy adults in Makueni county, Eastern Kenya, a region with recurring aflatoxin outbreaks.

Urine aflatoxin M1 was about half as high while taking clay as on placebo (ratio 0.49, 95% CI 0.32 to 0.75), although no single day differed significantly. Taste, aftertaste, appearance, color, texture and self-reported adverse events did not differ, and 98% said they would take it; smell was rated slightly worse on clay (0.25 points on a 5-point scale). A short trial in people with lower exposure than during outbreaks.

7
Beidellitic Montmorillonite (a Medicinal Clay) in IBS: 8-Week Multicenter RCT
PubMed

Multicenter, double-blind, placebo-controlled, randomized parallel-group trial of beidellitic montmorillonite 3 g three times daily for 8 weeks, with rescue laxative and antispasmodic allowed. (Ducrotte et al. 2005, Aliment Pharmacol Ther)

524 patients with IBS by Rome I criteria (263 clay, 261 placebo), stratified by diarrhea-predominant, constipation-predominant and alternating bowel habit.

The primary endpoint, at least 1 point of improvement in abdominal pain or discomfort, did not differ significantly overall (51.7% clay vs 45.2% placebo). In the constipation-predominant subgroup it favored clay (49.4% vs 31.5%, P < 0.016). Stool frequency did not change and rescue medication use was similar. No significant adverse events were reported.

Side effects and drug interactions

Common Potential side effects

Mild digestive effects in short trials of refined clay: abdominal pain, bloating, gas, constipation or diarrhea each in 2 to 8% of 50 adults over 2 weeks; over 3 months, nausea, diarrhea, heartburn and dizziness were as common as on placebo.
Contamination: in 2016 the FDA told consumers not to buy or use "Best Bentonite Clay" or Alikay Naturals "Bentonite Me Baby" after its labs found elevated lead; both were sold to be swallowed or applied. The FDA confirmed no lead poisoning cases.
A Dutch survey of clays for oral use estimated that 2 of 27 health clays would exceed the toxicological limit for lead and 11 of 27 the limit for inorganic arsenic at their typical use levels.
Severe potassium loss (serum potassium 0.9 mmol/L, with vomiting and weakness) in a 3-year-old given a colloidal bentonite remedy by mouth and rectally for constipation; the authors noted large amounts can bind electrolytes and may cause obstruction.
Serum strontium rose in adults taking 3 g/day of refined clay for 3 months.
Avoid in pregnancy, breastfeeding and young children: Dutch food safety researchers advised that pregnant women not use oral clays because of lead and arsenic, and France advises against medicinal diosmectite under age 2 and in pregnancy or breastfeeding.

Important Drug interactions

Oral medicines: no interaction studies were found, but clay is taken to bind substances in the gut, so separating it from other medicines by at least 2 hours is a sensible precaution; ask a pharmacist about narrow-margin drugs such as levothyroxine, warfarin, digoxin or lithium.
Diuretics and other drugs that lower potassium: severe potassium loss was reported in a child given bentonite by mouth and rectally, so the combination calls for caution.
Iron, zinc, calcium and magnesium supplements: 3 g/day of refined clay did not change serum minerals in a 3-month trial, but larger retail doses were not tested; take them at a different time.
Other binders such as activated charcoal, zeolite or cholestyramine: stacking adsorbents raises the chance of blocking medicines and nutrients.

Frequently asked questions about Bentonite Clay (Oral)

Is the clay used in the aflatoxin studies the same as bentonite sold online?

Not necessarily. The trials used refined, tested calcium montmorillonite clays (NovaSil, Uniform Particle Size NovaSil and ACCS100) at measured doses of 1.5 to 3 g a day. Retail bentonite comes from different deposits and is not held to the same testing, and surveys have found lead or arsenic in some clays sold for oral use. The trial results cannot be assumed for any particular retail product.

Why did the FDA warn people about some bentonite clay products?

In 2016 FDA laboratories found elevated lead in two bentonite clay products, "Best Bentonite Clay" and Alikay Naturals "Bentonite Me Baby", both sold to be swallowed or applied. The FDA told consumers not to buy or use them and to see a health care professional if they or a child had used them. It had not confirmed any lead poisoning cases.

Can bentonite clay pull heavy metals or toxins out of the body?

No trial cited here tested removal of metals or toxins already stored in the body. The human studies measured markers of mold toxins eaten in food during the study period, which fell with refined clay. Clay itself can carry lead and arsenic, so an untested product could add metals rather than remove them.

Does bentonite clay interfere with nutrients or medicines?

At 3 g a day for 3 months, refined clay did not change serum vitamins A and E or nutrient minerals, though strontium rose. A child given a bentonite remedy by mouth and rectally developed severe potassium loss. Medicines were not studied, so taking clay at least 2 hours apart from other medicines and supplements is a sensible precaution.

What is Bentonite Clay?

Bentonite clay is a natural clay sold as a powder or liquid to swallow, often marketed for detox and digestion. The human research is narrow and comes almost entirely from refined calcium montmorillonite clays (NovaSil and related forms) tested in people with high dietary exposure to aflatoxin, a mold toxin found in po…

What is Bentonite Clay used for?

NutraSmarts does not list Bentonite Clay under a health category. What the research covers: In a 3-month placebo-controlled trial in 177 Ghanaian adults with high dietary aflatoxin exposure, capsules of refined calcium montmorillonite (1.

What is the recommended dosage of Bentonite Clay?

The clinically studied dose is 1.5 or 3 g/day of refined calcium montmorillonite in capsules for 2 weeks to 3 months; 3 g/day stirred into water for 7 days; 0.75 or 1.5 g/day for 14 days in children. Medicinal beidellitic montmorillonite: 3 g three times daily for 8 weeks. Always follow the product label and check with a healthcare provider for personal advice.

Is Bentonite Clay safe, and does it have side effects?

Side effects and cautions reported for Bentonite Clay include: Mild digestive effects in short trials of refined clay: abdominal pain, bloating, gas, constipation or diarrhea each in 2 to 8% of 50 adults over 2 weeks; over 3 months, nausea, diarrhea, heartburn and dizziness were as common as on placebo. It may also interact with some medications. Bentonite Clay is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Bentonite Clay interact with any medications?

Possible interactions include: Oral medicines: no interaction studies were found, but clay is taken to bind substances in the gut, so separating it from other medicines by at least 2 hours is a sensible precaution; ask a pharmacist about narrow-margin drugs such as levothyroxine, warfarin, digoxin or lithium. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Bentonite Clay?

NutraSmarts rates the evidence for Bentonite Clay as Limited (2 out of 5). It is backed by 7 study summaries and 16 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(16 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Wang JS, Luo H, Billam M, Wang Z, Guan H, Tang L, Goldston T, Afriyie-Gyawu E, Lovett C, Griswold J, Brattin B, Taylor RJ, Huebner HJ, Phillips TD. Short-term safety evaluation of processed calcium montmorillonite clay (NovaSil) in humans. Food Addit Contam. 2005;22(3):270-9. doi: 10.1080/02652030500111129.PubMedUsed to support: Randomized, double-blind phase I trial in 50 healthy adults taking 1.5 or 3 g/day of NovaSil clay for 2 weeks: mild digestive effects in 2 to 8% each, no difference between doses, and no significant changes in blood counts, liver and kidney tests, electrolytes, vitamins A and E or minerals. No placebo arm.
  2. Afriyie-Gyawu E, Ankrah NA, Huebner HJ, Ofosuhene M, Kumi J, Johnson NM, Tang L, Xu L, Jolly PE, Ellis WO, Ofori-Adjei D, Williams JH, Wang JS, Phillips TD. NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008;25(1):76-87. doi: 10.1080/02652030701458105.PubMedUsed to support: Double-blind, placebo-controlled 3-month phase IIa trial in 177 Ghanaian adults (162 completed) taking 3 g/day, 1.5 g/day or placebo: side effects were rare and statistically similar across groups, and blood counts, liver and kidney function and electrolytes did not differ.
  3. Wang P, Afriyie-Gyawu E, Tang Y, Johnson NM, Xu L, Tang L, Huebner HJ, Ankrah NA, Ofori-Adjei D, Ellis W, Jolly PE, Williams JH, Wang JS, Phillips TD. NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis: II. Reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008;25(5):622-34. doi: 10.1080/02652030701598694.PubMedUsed to support: Biomarker results of the Ghana trial: the blood aflatoxin-albumin marker was significantly lower with 1.5 and 3 g/day than placebo at 3 months but not at 1 month, and median urine aflatoxin M1 was up to 58% lower with 3 g/day at 3 months. Exposure markers, not health outcomes.
  4. Afriyie-Gyawu E, Wang Z, Ankrah NA, Xu L, Johnson NM, Tang L, Guan H, Huebner HJ, Jolly PE, Ellis WO, Taylor R, Brattin B, Ofori-Adjei D, Williams JH, Wang JS, Phillips TD. NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008;25(7):872-84. doi: 10.1080/02652030701854758.PubMedUsed to support: In the 177-person Ghana trial, serum vitamins A and E and nutrient minerals did not differ between 3 g/day of NovaSil and placebo over 3 months; serum strontium was significantly higher in the 3 g/day group.
  5. Robinson A, Johnson NM, Strey A, Taylor JF, Marroquin-Cardona A, Mitchell NJ, Afriyie-Gyawu E, Ankrah NA, Williams JH, Wang JS, Jolly PE, Nachman RJ, Phillips TD. Calcium montmorillonite clay reduces urinary biomarkers of fumonisin B₁ exposure in rats and humans. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2012;29(5):809-18. doi: 10.1080/19440049.2011.651628.PubMedUsed to support: Urine from weeks 8 and 10 of the Ghana trial: 56% of 186 samples had detectable fumonisin B1, and the median level was more than 90% lower with 3 g/day of NovaSil than with placebo. In rats, a single dose with clay lowered urinary fumonisin B1 by 20% at 24 hours and 50% at 48 hours.
  6. Mitchell NJ, Kumi J, Aleser M, Elmore SE, Rychlik KA, Zychowski KE, Romoser AA, Phillips TD, Ankrah NA. Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children. Am J Trop Med Hyg. 2014;91(4):777-85. doi: 10.4269/ajtmh.14-0093.PubMedUsed to support: Placebo-controlled trial in Ghanaian children given 0.75 or 1.5 g/day of Uniform Particle Size NovaSil or calcium carbonate placebo for 14 days: blood counts and blood chemistry did not differ from placebo, no adverse events were attributed to the clay, and a urine aflatoxin marker fell with the higher dose.
  7. Pollock BH, Elmore S, Romoser A, Tang L, Kang MS, Xue K, Rodriguez M, Dierschke NA, Hayes HG, Hansen HA, Guerra F, Wang JS, Phillips T. Intervention trial with calcium montmorillonite clay in a south Texas population exposed to aflatoxin. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2016;33(8):1346-54. doi: 10.1080/19440049.2016.1198498.PubMedUsed to support: Randomized, double-blind, placebo-controlled trial in 234 healthy Texas adults taking 1.5 or 3 g/day of ACCS100 for 3 months: the blood aflatoxin-lysine marker fell in both clay groups, but significantly only with 1.5 g/day; adverse events, blood chemistry and blood counts were similar across groups. Texas EnteroSorbents provided the clay at no cost (PMC full text).
  8. Awuor AO, Yard E, Daniel JH, Martin C, Bii C, Romoser A, Oyugi E, Elmore S, Amwayi S, Vulule J, Zitomer NC, Rybak ME, Phillips TD, Montgomery JM, Lewis LS. Evaluation of the efficacy, acceptability and palatability of calcium montmorillonite clay used to reduce aflatoxin B1 dietary exposure in a crossover study in Kenya. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2017;34(1):93-102. doi: 10.1080/19440049.2016.1224933.PubMedUsed to support: Double-blind crossover trial in 50 Kenyan adults: 3 g/day of ACCS100 stirred into water for 7 days roughly halved urine aflatoxin M1 compared with calcium carbonate placebo (ratio 0.49), with no differences in taste ratings or self-reported adverse events. The clay was supplied by Texas EnteroSorbents.
  9. Phillips TD, Wang M, Elmore SE, Hearon S, Wang JS. NovaSil clay for the protection of humans and animals from aflatoxins and other contaminants. Clays Clay Miner. 2019;67(1):99-110. doi: 10.1007/s42860-019-0008-x.PubMedUsed to support: Review by the research group that developed NovaSil: the clay binds aflatoxins in the gastrointestinal tract and lowers their bioavailability, mainly shown in animals, and in Ghanaian studies it lowered aflatoxin exposure markers without changing serum vitamins A and E, iron or zinc. Background for the mechanism, written by the clay's developers.
  10. Reeuwijk NM, Klerx WN, Kooijman M, Hoogenboom LA, Rietjens IM, Martena MJ. Levels of lead, arsenic, mercury and cadmium in clays for oral use on the Dutch market and estimation of associated risks. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2013;30(9):1535-45. doi: 10.1080/19440049.2013.811297.PubMedUsed to support: Analysis of 63 clays for oral use sold in the Netherlands (36 traditional, 27 health clays): maximum levels of 99.7 mg/kg lead and 45.1 mg/kg arsenic. Estimated intakes from 2 of 27 health clays exceeded the toxicological limit for lead and from 11 of 27 the limit for inorganic arsenic; the authors advised discouraging use, especially in pregnancy.
  11. Bennett A, Stryjewski G. Severe hypokalemia caused by oral and rectal administration of bentonite in a pediatric patient. Pediatr Emerg Care. 2006;22(7):500-2. doi: 10.1097/01.pec.0000227873.05119.e6.PubMedUsed to support: Case report of a 3-year-old given a colloidal bentonite home remedy by mouth and rectally who developed vomiting, lethargy, weakness and a serum potassium of 0.9 mmol/L, which normalized with potassium replacement. The authors note large clay intakes can bind electrolytes and may cause obstruction, and suggest the rectal route may explain why this was the first reported case of hypokalemia caused specifically by bentonite.
  12. Pérez-Gaxiola G, Cuello-García CA, Florez ID, Pérez-Pico VM. Smectite for acute infectious diarrhoea in children. Cochrane Database Syst Rev. 2018;4(4):CD011526. doi: 10.1002/14651858.CD011526.pub2.PubMedUsed to support: Cochrane review of 18 trials in 2,616 children: smectite given with rehydration may shorten acute infectious diarrhea by about a day (low-certainty evidence) but did not change hospitalization. Constipation was the most frequently reported side effect and did not differ between groups. Medical drug use, cited as context only.
  13. Ducrotte P, Dapoigny M, Bonaz B, Siproudhis L. Symptomatic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a randomized, controlled trial. Aliment Pharmacol Ther. 2005;21(4):435-44. doi: 10.1111/j.1365-2036.2005.02330.x.PubMedUsed to support: Double-blind, placebo-controlled 8-week trial in 524 IBS patients: beidellitic montmorillonite did not significantly beat placebo on the primary pain or discomfort endpoint overall (51.7% vs 45.2%), but did in the constipation-predominant subgroup (49.4% vs 31.5%); stool frequency did not change.
  14. US Food and Drug Administration. FDA Warns Consumers Not to Use "Best Bentonite Clay". FDA Drug Safety and Availability (archived web page). 2016;Consumer warning dated 23 March 2016; read via the Internet Archive copy of the original fda.gov page..SourceUsed to support: Not PubMed-indexed. FDA warning that its laboratories found elevated lead in "Best Bentonite Clay" (Best Bentonite, Guthrie, Oklahoma), sold as a fine powder on Amazon.com and the company website, which said customers mix it with water and swallow it or apply it to skin; consumers should not buy or use it, and FDA had confirmed no lead poisoning cases.
  15. US Food and Drug Administration. FDA warns consumers about health risks with Alikay Naturals - Bentonite Me Baby - Bentonite Clay. FDA Drug Safety and Availability (archived web page). 2016;Consumer warning, page last updated 23 March 2016; read via the Internet Archive copy of the original fda.gov page..SourceUsed to support: Not PubMed-indexed. FDA warning that its laboratory analysis found elevated lead in "Bentonite Me Baby" by Alikay Naturals, marketed as medicinal clay to be ingested or applied to hair and skin and sold at Target, Amazon.com and Sally Beauty Supply. The tip came from the Minnesota Department of Health; FDA had confirmed no lead poisoning cases.
  16. Agence nationale de sécurité du médicament et des produits de santé (ANSM). Médicaments à base d'argile dans le traitement symptomatique de la diarrhée aigüe chez l'enfant. ANSM (French medicines agency) web page. 2019;Published 28 February 2019, updated 16 March 2021..SourceUsed to support: Not PubMed-indexed. French medicines agency notice: as a precaution, diosmectite medicines (Smecta and a generic) should no longer be given to children under 2 because clays from the soil may contain traces of naturally occurring lead; a manufacturer study found no lead passing into the blood in adults treated for 5 weeks; no lead poisoning cases were known; not recommended in pregnancy or breastfeeding; other clay medicines are for adults only.