Abstract | BACKGROUND & AIMS: METHODS: Two parallel, double-blind studies of diosmectite efficacy on stool reduction were conducted in children 1 to 36 months old in Peru (n = 300) and Malaysia (n = 302). Inclusion criteria included 3 or more watery stools per day for less than 72 hours and weight/height ratios of 0.8 or greater. Exclusion criteria were the need for intravenous rehydration, gross blood in stools, fever higher than 39 degrees C, or current treatment with antidiarrheal or antibiotic medications. Rotavirus status was determined. Diosmectite dosage was 6 g/day (children 1-12 months old) or 12 g/day (children 13-36 months old), given for at least 3 days, followed by half doses until complete recovery. Patients were assigned randomly to groups given diosmectite or placebo, in addition to oral rehydration solution (World Health Organization). RESULTS: Children in each study had comparable average ages and weights. The frequencies of rotavirus infection were 22% in Peru and 12% in Malaysia. Similar amounts of oral rehydration solution were given to children in the diosmectite and placebo groups. Stool output was decreased significantly by diosmectite in both studies, especially among rotavirus-positive children. In pooled data, children had a mean stool output of 94.5 +/- 74.4 g/kg of body weight in the diosmectite group versus 104.1 +/- 94.2 g/kg in the placebo group (P = .002). Diarrhea duration was reduced by diosmectite, which was well tolerated. CONCLUSIONS: These results show that diosmectite significantly decreased stool output in children with acute watery diarrhea, especially those who were rotavirus-positive.
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Authors | Christophe Dupont, Jimmy Lee Kok Foo, Philippe Garnier, Nicholas Moore, Hèlène Mathiex-Fortunet, Eduardo Salazar-Lindo, Peru and Malaysia Diosmectite Study Groups |
Journal | Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
(Clin Gastroenterol Hepatol)
Vol. 7
Issue 4
Pg. 456-62
(Apr 2009)
ISSN: 1542-7714 [Electronic] United States |
PMID | 19268266
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Gastrointestinal Agents
- Placebos
- Silicates
- Smectite
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Topics |
- Child, Preschool
- Diarrhea
(drug therapy)
- Double-Blind Method
- Feces
- Gastrointestinal Agents
(administration & dosage, therapeutic use)
- Humans
- Infant
- Malaysia
- Male
- Peru
- Placebos
(administration & dosage)
- Rotavirus
(isolation & purification)
- Silicates
(administration & dosage, therapeutic use)
- Time Factors
- Treatment Outcome
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