Control randomized study of rehydration/rehydration with dioctahedral smectite in ambulatory Thai infants with acute diarrhea.

The study was performed to assess the efficiency, acceptability and safety of dioctahedral smectite (DS) associated with rehydration in ambulatory infants with acute diarrhea. Sixty-six Thai infants, aged 1-24 months were randomly divided into 2 groups. One group of 32 infants (control group) received oral or intravenous rehydration, the other group of 34 infants (DS group) received the rehydration with DS. Both groups were comparable for sex, age, weight, diet, duration of diarrhea, body temperature, nutritional and dehydration status. Bacteriological stool examination was positive in 22% in control group and 26% in DS group for Salmonella, Shigella, Campylobacter, enterotoxigenic Escherichia coli and Plesiomonas sp. Rotavirus was found in 25% of the control group and 29% of the DS group. Seventy-two hours after therapy, 34% of infants were cured in the control group compared to 71% in DS group (p < 0.01) and 5 days after the beginning of treatment, 34% still had diarrhea in the control group compared to 12% in DS group (p = 0.04). The acceptability of DS was considered to be good in 30 infants (88%). No major side effect was observed. In conclusion, DS with rehydration shortens the course of acute diarrhea in ambulatory infants and may reduce the occurrence of prolonged diarrhea. DS is well tolerated in infants with acute diarrhea.

Control study of oral rehydration solution (ORS)/ORS + dioctahedral smectite in hospitalized Thai infants with acute secretory diarrhea.

Dioctahedral smectite, a non systemic antidiarrheal agent, is mucoprotective and absorbs enterotoxins and rotavirus as demonstrated in animal models. Smectite has been successfully used in various countries in children and adults with acute diarrhea. This study was to assess the efficiency of smectite associated with rehydration in infants with acute secretory diarrhea. Sixty-two hospitalized Thai infants, aged 1-24 months, with acute secretory diarrhea were randomly divided into 2 groups receiving (1) oral rehydration solution (ORS) (30 cases), (2) ORS and Smectite (3.6 g/day) (32 cases). Both groups were comparable for age, weight, nutritional status and duration of symptoms before treatment. All 62 infants received lactose free formula and chicken rice soup as the standard diet. Stool frequency, weight change and duration of diarrhea were recorded. The mean duration of diarrhea was 84.7 +/- 48.5 hours in group 1, and 43.3 +/- 25.1 hours in group 2 (p = 0.005). The number of infants with diarrhea was significantly lower in group 2 on Day 1 (p < 0.01) and Day 3 (p = 0.001); furthermore 27% of infants in group 1 and 3% in group 2 had still diarrhea on Day 5. The stool frequency and weight changes were not statistically different in the two groups. No major side effects were observed except two cases of vomiting and hardened stools. It is concluded that (1) Smectite shortens the course of acute secretory diarrhea in Thai infants; (2) smectite may reduce the occurrence of prolonged diarrhea; furthermore (3) in our study dioctahedral smectite was found to be safe in children aged 1 to 24 months.