Evidence map›Paper›PMID 26832746›Full record

Trial reportBMC complementary and alternative medicine2016

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

Yana Emmy Hoy-Schulz, Kaniz Jannat, Thomas Roberts, Saira Husain Zaidi, Leanne Unicomb, Stephen Luby, Julie Parsonnet

2 registry-linked trialsAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01899378 phase1completednot on this map

Safety and Efficacy of Probiotics in Bangladeshi Infants

TypeinterventionalSponsorStanford UniversityRan2013 to 2014Enrolled160ConditionsHealthyArmsLactobacillus reuteri DSM 17938, Bifidobacterium longum infantis
NCT05524649 narecruitingnot on this mapstarted 2022, after this paper: background citation

Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants

TypeinterventionalSponsorAB Biotics, SARan2022 to 2025Enrolled120ConditionsMicrobial ColonizationArmsFood Supplement 1, Food Supplement 2, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Probiotics to prevent infantile colic.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Effectiveness ofInternational journal of clinical pediatric dentistry · 2026
    Article
  7. Probiotic Dairy Innovations: Exploring Buffalo Milk Potential for Food Product Development.Comprehensive reviews in food science and food safety · 2025
    Review
  8. Article
  9. Effects ofNutrients · 2024
    Article
  10. Review
  11. Article
  12. Article
  13. Slums, Space, and State of Health-A Link between Settlement Morphology and Health Data.International journal of environmental research and public health · 2020
    Article
  14. Article
  15. Exploiting Prophage-Mediated Lysis for Biotherapeutic Release byApplied and environmental microbiology · 2019
    Article
  16. Article
  17. Role ofFrontiers in microbiology · 2018
    Review
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yana Emmy Hoy-SchulzDepartment 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.
Kaniz JannatInternational Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh. kaniz72@icddrb.org.
Thomas RobertsDepartment 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.
Saira Husain ZaidiSchool of Public Health, University of California, Berkeley, Berkeley, CA, USA. sairahusain618@gmail.com.
Leanne UnicombInternational Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh. leanne@icddrb.org.
Stephen LubyDepartment 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.
Julie ParsonnetDepartment 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.

Funding

Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1RR025744 · NCRR · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2008 to 2011
$22.4M
Research Mentoring and Building Capacity of underrepresented Minority Research Scientists in India.D43TW010540 · FIC · YALE UNIVERSITY · PI MICHELE BARRY, Eva Harris · 2017 to 2026
$15.5M
Spectrum Stanford Center for Clinical and Translational Research and EducationTL1TR001084 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$1.1M
FIC NIH HHS D43 TW010540NCATS NIH HHS TL1 TR001084NCATS NIH HHS UL1 TR001085NCRR NIH HHS UL1 RR025744NCRR NIH HHS UL1RR025744
6 · The paper itself

Abstract

backgroundProbiotics 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.

methodsHealthy 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.

resultsIn 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.

conclusionsThese two commonly used probiotics appeared safe and well-accepted by Bangladeshi families.

trial registrationClinicalTrials.gov NCT01899378 . Registered July 10, 2013.

Indexed as

BifidobacteriumLimosilactobacillus reuteriProbioticsBangladeshHumansInfantInfant, Newborn

Identifiers

PMID26832746
PMCPMC4736167

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.