OBJECTIVE: To evaluate the effect of feeding infants a soy-based formula with lactose compared with a soy-based formula with sucrose during an acute diarrheal episode. PARTICIPANTS AND METHODS: Two hundred boys, aged 3 to 18 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive a soy-based formula with lactose or sucrose after initial rehydration. Intake and output (stool, urine, and vomit) were measured and recorded every 3 hours until diarrhea resolved. RESULTS: The stool output during the first 24 hours of maintenance therapy, the total stool output during maintenance therapy, and the stool output during the entire illness (measured in grams per kilograms) were significantly lower among patients who received the soy-based formula with sucrose (P<.05, P<.001, and P<.001, respectively) than among patients who received the soy-based formula with lactose. The duration of diarrhea was significantly shorter among patients who received the soy-based formula with sucrose (P<.001). The relative risk of being withdrawn from the study increased to 1.95 (95% confidence interval, 0.65-9.2) and the relative risk of recurrence of dehydration after feeding was initiated increased significantly to 3.49 (95% confidence interval, 1.1-9.6; P<.01) in the group receiving the soy-based formula with lactose. CONCLUSION: During diarrheal episodes, feeding infants a soy-based formula with sucrose has a better outcome (lower stool output, shorter duration of diarrhea, and lower failure rates) than feeding infants a soy-based formula with lactose.
RCT Entities:
OBJECTIVE: To evaluate the effect of feeding infants a soy-based formula with lactose compared with a soy-based formula with sucrose during an acute diarrheal episode. PARTICIPANTS AND METHODS: Two hundred boys, aged 3 to 18 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive a soy-based formula with lactose or sucrose after initial rehydration. Intake and output (stool, urine, and vomit) were measured and recorded every 3 hours until diarrhea resolved. RESULTS: The stool output during the first 24 hours of maintenance therapy, the total stool output during maintenance therapy, and the stool output during the entire illness (measured in grams per kilograms) were significantly lower among patients who received the soy-based formula with sucrose (P<.05, P<.001, and P<.001, respectively) than among patients who received the soy-based formula with lactose. The duration of diarrhea was significantly shorter among patients who received the soy-based formula with sucrose (P<.001). The relative risk of being withdrawn from the study increased to 1.95 (95% confidence interval, 0.65-9.2) and the relative risk of recurrence of dehydration after feeding was initiated increased significantly to 3.49 (95% confidence interval, 1.1-9.6; P<.01) in the group receiving the soy-based formula with lactose. CONCLUSION: During diarrheal episodes, feeding infants a soy-based formula with sucrose has a better outcome (lower stool output, shorter duration of diarrhea, and lower failure rates) than feeding infants a soy-based formula with lactose.