Randomized Controlled Trial Evaluating Probiotics in Children with Severe Acute Malnutrition: Evidence-based Medicine Viewpoint.

Abstract

This randomized, double-blind, placebo-controlled trial was conducted involving 400 children hospitalized with severe acute malnutrition (SAM). Patients received one daily dose of a blend of Bifidobacterium animalis subsp lactis and Lactobacillus rhamnosus (10 billion colony-forming units, 50:50) or placebo during hospitalization followed by an 8- to 12-week outpatient treatment period, depending on patients’ recovery rate. The primary outcome was number of days with diarrhea during hospitalization. Secondary outcomes included other diarrhea outcomes, pneumonia, weight gain, and recovery. 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% confidence interval -0.8 to 1.2, P=0.69); however, during outpatient treatment, probiotics reduced days with diarrhea (adjusted difference -2.2 days 95% confidence interval -3.5 to -0.3, P=0.025). Twenty-six patients died in the probiotic versus 20 in the placebo group (P=0.38). The authors concluded that these probiotics had no effect on diarrhea in children with SAM during hospitalization, but reduced the number of days with diarrhea in outpatient treatment by 26%.