COWS MILK VERSUS SOY-BASED FORMULA IN MILD AND MODERATE DIARRHEA - A RANDOMIZED, CONTROLLED TRIAL

We determined the efficacy of a soy-based formula compared with a cow's milk formula in infant refeeding after acute diarrhea in a randomized controlled double-blind clinical trial. Infants 2-12 months of age with diarrhea of less than one week's duration and mild or moderate dehydration admitted to a pediatric hospital or in the practice of a participating primary care pediatrician were investigated. Seventy-six patients were enrolled and 73 completed the study; 39 infants received a soy-based formula (Isomil) and 34 received a cow's milk formula (SMA). Hospitalized patients were rehydrated with an oral glucose-electrolyte solution or an iv dextrose-sodium solution. Outpatients received oral glucose-electrolyte solution. In all patients, the study formula was commenced ad libitum during the first 24 h as determined by the attending pediatrician. The primary outcome measure was duration of diarrhea, defined as time to first normal stool, when subsequent stools were normal for a 24-h period. In addition, a predetermined secondary outcome was proportion of treatment failures, defined as the need to reinstitute clear fluids because of emesis, refusal to accept study formula, need for iv fluids due to negative fluid balance or diarrhea persisting beyond 7 days after enrollment. Total duration of diarrhea was significantly longer (p=0.03) in those receiving cow's milk (mean+/-SD 6.6+/-4.2 days) than in those receiving soy-based formula (4.5+/-3.6 days). Volume of formula intake and weight gain at 14 days were not different in the two groups. There were is treatment failures in the cow's milk formula recipients and 13 failures in the soy formula recipients (p=0.08). Soy-based formula significantly shortened the duaration of acute diarrhea in well nourished infants compared with cow's milk formula.