A Double Blind Randomized Trial Showing Probiotics to be Ineffective in Acute Diarrhea in Indonesian Children

Abstract

Objective: To investigate the efficacy of probiotics added to oral rehydration solution and zinc in the treatment of acute infectious diarrhea in Indonesian children. Methods: A prospective randomized double blind placebo-controlled trial was performed to test the efficacy of a probiotic food supplement in 112 children in the Kenari subdistrict, central Jakarta, aged 6–36 mo with acute infectious diarrhea and moderate dehydration. The supplemented group was given standard therapy (oral rehydration solution and zinc) and the probiotic strains Lactobacillus (L.) rhamnosus R0011 1.9 × 10 9 colony forming units (cfu) and L. acidophilus R0052 0.1 × 10 9 cfu/d for 7 d, while the control group was given standard therapy and placebo. Results: Median duration of diarrhea was 68.5 h (range 13–165) in the supplemented and 61.5 h (range 21–166) in the control group (P = 0.596). Median daily frequency of defecation until diarrhea stopped was 5.0 in the supplemented vs. 5.5 in the control group (P = 0.795). Conclusions: This probiotic food supplement tested did not reduce the duration of acute infectious diarrhea as compared to oral rehydration and zinc.