CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Thermophilic amylase-digested rice-electrolyte solution in the treatment of acute diarrhea in children.

Pediatrics 1995 Februrary
OBJECTIVE: To compare the efficacy of an oral rehydration solution (ORS) containing short polymers of glucose derived from rice (Amylyte-ORS) and five times the caloric density of current ORS to the standard glucose-ORS (World Health Organization [WHO] = ORS) in the treatment of acute diarrhea in children.

METHODS: The rice ORS (Amylyte-ORS) was obtained by adding thermophilic amylase (252,500 MW units) and salts (1.5 g NaCl, 600 mg KCl, and 150 mg CaCl2) to 100 g rice and boiling for 10 minutes in 500 mL water. This yields 250 mL Amylyte-ORS, which contains 92% to 96% short-chain glucose polymers, three to nine molecules in length, and provides 425 kcal/L, compared to 80 kcal/L for the WHO-ORS. One hundred forty-four male children, 4 months to 3 years of age, presenting with acute diarrhea and mild, moderate, or severe dehydration, were assigned by random allocation to receive either WHO-ORS or Amylyte-ORS. Data from 127 children were analyzed (57 received the WHO-ORS and 70 the Amylyte-ORS). Two children given Amylyte-ORS and 15 given the WHO-ORS were not included in the analysis because of improperly collected data or lost urine or fecal specimens. None were given antibiotics during the study. Free water and feeding were allowed after the children were rehydrated.

RESULTS: The clinical characteristics of the children in the two treatment groups were comparable. Five children who received the WHO-ORS and three children given Amylyte-ORS were treatment failures. Amylyte-ORS reduced diarrhea duration by 15% (41.4 +/- 2.5 vs 34.7 +/- 1.8 hours; P < .03) compared to the WHO-ORS, regardless of the severity of dehydration. In the Amylyte-treated group, ORS requirements were significantly less (234 +/- 15.2 vs 295 +/- 17.6 mL/kg; P < .01) and weight gain was significantly more (367.7 +/- 45.1 vs 199.2 +/- 38.2 g; P < .01) than in those given the WHO-ORS. The net intestinal fluid balance and total body fluid balance were similar in the two groups.

CONCLUSIONS: Amylyte-ORS effectively rehydrates children with acute diarrhea, reduces diarrhea duration, decreases ORS requirements, and improves weight gain compared to the WHO-ORS.

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