CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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Role of soy-based, lactose-free formula during treatment of acute diarrhea.

Pediatrics 1985 August
A controlled study was conducted comparing the standard method of treating hospitalized infants with acute diarrhea (limited starvation) with the initiation of "early feeding" using a soy-based, lactose-free formula in infants of an American Indian tribe 12 months of age or younger. Forty-three patients, randomly assigned to group A, were given a soy-based, lactose-free formula four hours after hospitalization, and 44 patients, randomly assigned to group B, received standard therapy (food was withheld for the first 48 hours of hospitalization). After the first 48 hours, the same soy-based, lactose-free formula was given to the group B patients. Fluid intake and output of stool, urine, and vomitus were measured until the diarrhea resolved. Overall, group A patients showed less mean stool output (121 +/- 129 (SD) mL/kg) than group B patients (299 +/- 319 mL/kg) (P less than .001). Furthermore, the duration of illness was significantly shorter in group A patients (54 +/- 28 hours v 93 +/- 56 hours) (P less than .001). It was concluded that soy-based, lactose-free formulas can be safely used during the acute phase of diarrheal illness in infants and that their use shortens the duration of illness and decreases stool output in comparison with standard therapy.

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