[Clinical trial on the prevention of diarrhea by oral BIFICO for infants aged 1-6 years].

Abstract

Objective: To investigate the prevention of diarrhea by oral BIFICO for infants aged 1-6 years.

Methods: 490 cases of infants were randomly divided after age stratification: the experimental group (n = 247) and the control group (n = 243). Based on principles of randomized double-blind and placebo-controlled, the infants were given BIFICO (dedicated clinical research)therapy for 4 consecutive days, then observed for 21 days. 25 days composed a cycle. They were observed total 5 cycles. During the study period, principles for "the diarrhoea patients must be detected", follow-up visited the participant infants and conducted etiology detection by way of sampling for diarrhea infants. Evaluate the prevention efficacy of diarrhea by oral BIFICO for infants aged 1-6 years.

Results: A total of 480 completed all study. 120 and 95 infants in the control group and experimental group were detected with diarrhea. The incidence of diarrhea was 50.85% and 38.93% in these two guoup, respectively. The difference has statistical significance (chi2 = 4.175, P = 0.041). In the third observation period, the infants in the control group had a higer incidence of diarrhea compared with which in the experimental group (chi2 = 4.415, P = 0.036). 14 strains of rotavirus, 3 strains of norovirus, 3 strains of sappovirus, 2 strains of adenovirus, 5 strains of salmonella and 4 strains of Shigella were check out in 128 samples.

Conclusion: Oral BIFICO can paly certain preventive role on diarrhea, and decrease the incidence of diarrhea in infants aged 1-6 years.