title: Effect of Probiotics on Diarrhea in Children With Severe Acute Malnutrition: A Randomized Controlled Study in Uganda.
abstract: The aim of the study was to assess the effect of probiotics on diarrhea during in- and outpatient treatment of children with severe acute malnutrition (SAM).
  
  
  
  A randomized, double-blind, placebo-controlled study was conducted involving 400 children admitted with SAM. Patients received 1 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. 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.
  
  
  
  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). 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).
  
  
  
  Bifidobacterium animalis subsp lactis and Lactobacillus rhamnosus 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.
authors.affiliation: *Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark †Mwanamugimu Nutrition Unit, Department of Pediatrics and Child Health, Mulago National Referral Hospital, Kampala, Uganda.
authors.forename: Benedikte
authors.initials: B
authors.lastname: Grenov
authors.forename: Hanifa
authors.initials: H
authors.lastname: Namusoke
authors.forename: Betty
authors.initials: B
authors.lastname: Lanyero
authors.forename: Nicolette
authors.initials: N
authors.lastname: Nabukeera-Barungi
authors.forename: Christian
authors.initials: C
authors.lastname: Ritz
authors.forename: Christian
authors.initials: C
authors.lastname: Mølgaard
authors.forename: Henrik
authors.initials: H
authors.lastname: Friis
authors.forename: Kim F
authors.initials: KF
authors.lastname: Michaelsen
mesh_terms: D000553:Ambulatory Care; D000069982:Bifidobacterium animalis; D002675:Child, Preschool; D003967:Diarrhea / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D007223:Infant; D057194:Intention to Treat Analysis; D052201:Lacticaseibacillus rhamnosus; D008297:Male; D015233:Models, Statistical; D019936:Probiotics / Q000627:therapeutic use*; D000067011:Severe Acute Malnutrition / Q000150:complications*; D016896:Treatment Outcome; D014454:Uganda