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Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial.

  • 2015-12
  • BMC complementary and alternative medicine 16(1)
    • Yana Emmy Hoy-Schulz
    • Kaniz Jannat
    • Thomas Roberts
    • Saira Husain Zaidi
    • Leanne Unicomb
    • Stephen Luby
    • Julie Parsonnet

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 160
Population
160 healthy infants aged four to twelve weeks from urban slums in Bangladesh
Methods
Randomized to daily, weekly, or biweekly 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.
Blinding
Open-label
Duration
one month of intervention, with two additional months of follow-up
Funding
Unclear
  • Large Human Trial

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.

Trial registration

ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.

Research Insights

Adverse Events Reported

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