Jia-Hua Xu1, Ying Huang. 1. Department of Gastroenterology, Children's Hospital of Fudan University, Shanghai 201102, China.
Abstract
OBJECTIVE: To study the efficiency of lactose-free formula feeding as an adjunctive therapy in infants with acute diarrhea. METHODS: A rigorous double-blind, randomized, controlled equivalence trial was performed. One hundred and twenty infants with acute diarrhea were randomly divided into two groups: lactose-free formula and conventional formula feeding. The two groups were given conventional medical treatment and oral rehydration therapy. The therapeutic effects were observed 1 week after treatment. RESULTS: The cure rate and the total effective rate were 58.3% and 96.7% respectively in the lactose-free formula group, and they were 8.3% and 85.0% respectively in the conventional formula group. There were significant differences in the therapeutic effect between the two groups (p<0.05). The duration of diarrhea remission (3.17+/-1.04 days) in the lactose-free formula group was significantly shorter than that in the conventional formula group (5.25+/-1.58 days) (p<0.05). After treatment the incidence of fecal flora disturbance was lower in the lactose-free formula group than that in the conventional formula group (p<0.05). No aderverse events were observed in the two groups. CONCLUSIONS:Lactose-free formula feeding together with conventional therapy can significantly shorten the disease course and improve the treatment outcome in infants with acute diarrhea.
RCT Entities:
OBJECTIVE: To study the efficiency of lactose-free formula feeding as an adjunctive therapy in infants with acute diarrhea. METHODS: A rigorous double-blind, randomized, controlled equivalence trial was performed. One hundred and twenty infants with acute diarrhea were randomly divided into two groups: lactose-free formula and conventional formula feeding. The two groups were given conventional medical treatment and oral rehydration therapy. The therapeutic effects were observed 1 week after treatment. RESULTS: The cure rate and the total effective rate were 58.3% and 96.7% respectively in the lactose-free formula group, and they were 8.3% and 85.0% respectively in the conventional formula group. There were significant differences in the therapeutic effect between the two groups (p<0.05). The duration of diarrhea remission (3.17+/-1.04 days) in the lactose-free formula group was significantly shorter than that in the conventional formula group (5.25+/-1.58 days) (p<0.05). After treatment the incidence of fecal flora disturbance was lower in the lactose-free formula group than that in the conventional formula group (p<0.05). No aderverse events were observed in the two groups. CONCLUSIONS:Lactose-free formula feeding together with conventional therapy can significantly shorten the disease course and improve the treatment outcome in infants with acute diarrhea.