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
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.
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.
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
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.
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.
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.
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.
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.
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.
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.