Probiotics in acute diarrhea: A randomized control trial

Abstract

Background: Probiotics have been used for long in the treatment of acute diarrhea although their efficacy has always remains the subject of discussion. Objective: To determine the effect of probiotics in acute diarrhea among the children in rural population. Method: Double-blinded randomized control trial. We included children of age group 6 months - 5 years suffering from acute diarrhea of <48 h and fulfilling the inclusion criteria. All children were given oral rehydration salts (ORS) ad-lib till the resolution of diarrhea and zinc 20 mg/day for 14 days while intervention arm (n=101) were given probiotic sachet twice a day for 7 days containing Streptococcus faecalis 30 million, Clostridium butyricum 2 million, Bacillus mesentericus 1 million, Lactobacillus sporogenes 50 million, control group were given identical placebo apart from ORS and zinc. Duration of diarrhea in both the groups was measured as primary outcome while secondary outcome was to know the days of maximum recovery from diarrhea in both groups. Results: Totally, 207 patients were randomized to control and study group, out of which, 195 completed the study. Out of total 195 patients, 94 (48.2%) patients were treatedwith standard treatment of diarrhea without probiotics while 101 (51.8%) patients were given probiotics apart from standard treatment of diarrhea. The mean duration of diarrhea was found to be reduced in the study group (4.6 days [2.84-4.776 days]) as compared to control group (5.31 days [5.108-5.512 days]), p<0.001. Conclusion: Probiotics significantly reduced the duration of acute diarrhea in children.