OBJECTIVES: To assess the effect of probiotics on diarrhea during in- and outpatient treatment of children with severe acute malnutrition (SAM).

METHODS: A randomized, double-blind, placebo-controlled study was conducted involving 400 children admitted with SAM. Patients received one daily dose of a blend of Bifidobacterium animalis subsp. lactis (BB-12) and Lactobacillus rhamnosus (LGG) (10 billion colony-forming units, 50:50) or placebo during hospitalization followed by an 8-12 week outpatient treatment period, depending on patients' recovery rate. All outcomes were reported for in- and outpatient treatment separately. The primary outcome was number of days with diarrhea during hospitalization. Secondary outcomes included other diarrhea outcomes, pneumonia, weight gain, and recovery.

RESULTS: There was no difference in number of days with diarrhea between the probiotic (n = 200) and placebo (n = 200) groups during inpatient treatment (adjusted difference +0.2 days, 95% CI -0.8 to 1.2, p = 0.69), however during outpatient treatment, probiotics reduced days with diarrhea (adjusted difference -2.2 days 95% CI -3.5 to -0.3, p = 0.025). There were no effects of probiotics on diarrhea incidence and severity or pneumonia, weight gain or recovery during in- or outpatient treatment. Twenty-six patients died in the probiotic versus 20 in the placebo group (p = 0.38).

CONCLUSION: BB-12 and LGG had no effect on diarrhea in children with SAM during hospitalization, but reduced the number of days with diarrhea in outpatient treatment by 26%. Probiotics may have a role in follow-up of hospitalized children with SAM or in community based treatment of malnourished children, but further studies are needed to confirm this.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.