title: Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial.
abstract: BACKGROUND
  Probiotics have rarely been studied in young healthy infants from low-income countries. This phase I study investigated the safety and acceptability of two probiotics in Bangladesh.
  
  
  METHODS
  Healthy infants aged four to twelve weeks from urban slums in Bangladesh were randomized to one of three different intervention dosing arms (daily, weekly, biweekly - once every two weeks) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics. All subjects were followed for two additional months. Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates, hospitalizations, differential withdrawals, and caretakers' perception of probiotic use were compared among arms.
  
  
  RESULTS
  In total, 160 infants were randomized (40 to each arm) with 137 (Daily n = 35, Weekly n = 35, Biweekly n = 35, Control n = 32) followed up for a median of twelve weeks; 113 completed the study. Illness and breastfeeding rates were similar across all arms. Ten hospitalizations unrelated to probiotic use occurred. Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby's health.
  
  
  CONCLUSIONS
  These two commonly used probiotics appeared safe and well-accepted by Bangladeshi families.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.
authors.affiliation: Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-107, Stanford, CA, USA. ehoy@stanford.edu.
authors.forename: Yana Emmy
authors.initials: YE
authors.lastname: Hoy-Schulz
authors.affiliation: International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh. kaniz72@icddrb.org.
authors.forename: Kaniz
authors.initials: K
authors.lastname: Jannat
authors.affiliation: Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-107, Stanford, CA, USA. tjroberts@stanford.edu.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roberts
authors.affiliation: School of Public Health, University of California, Berkeley, Berkeley, CA, USA. sairahusain618@gmail.com.
authors.forename: Saira Husain
authors.initials: SH
authors.lastname: Zaidi
authors.affiliation: International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh. leanne@icddrb.org.
authors.forename: Leanne
authors.initials: L
authors.lastname: Unicomb
authors.affiliation: Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-107, Stanford, CA, USA. sluby@stanford.edu.
authors.forename: Stephen
authors.initials: S
authors.lastname: Luby
authors.affiliation: Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-107, Stanford, CA, USA. parsonnt@stanford.edu.
authors.forename: Julie
authors.initials: J
authors.lastname: Parsonnet
mesh_terms: D001459:Bangladesh; D001644:Bifidobacterium; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D052200:Limosilactobacillus reuteri; D019936:Probiotics / Q000009:adverse effects
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