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Clinical Trial
. 2016 Feb 2:16:44.
doi: 10.1186/s12906-016-1016-1.

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  1 , Kaniz Jannat  2 , Thomas Roberts  3 , Saira Husain Zaidi  4 , Leanne Unicomb  5 , Stephen Luby  6 , Julie Parsonnet  7
Affiliations
Clinical Trial

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 et al. BMC Complement Altern Med. .

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.

Trial registration: ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.

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Figures

Fig. 1
Fig. 1
Study design and sampling scheme
Fig. 2
Fig. 2
Flow-chart of study screening, enrollment, and retention
See this image and copyright information in PMC

References

    1. WHO/FAO. Health and nutritional properties of powder milk with live lactic acid bacteria. Córdoba, Argentina: WHO/FAO; 2001.
    1. Thomas DW, Greer FR. Nutrition AAoPCo, American Academy of Pediatrics Section on Gastroenterology H, and Nutrition: Probiotics and prebiotics in pediatrics. Pediatrics. 2010;126(6):1217–31. doi: 10.1542/peds.2010-2548. - DOI - PubMed
    1. Ng SC, Hart AL, Kamm MA, Stagg AJ, Knight SC. Mechanisms of action of probiotics: recent advances. Inflamm Bowel Dis. 2009;15(2):300–10. doi: 10.1002/ibd.20602. - DOI - PubMed
    1. Lin A, Bik EM, Costello EK, Dethlefsen L, Haque R, Relman DA, et al. Distinct distal gut microbiome diversity and composition in healthy children from Bangladesh and the United States. PLoS One. 2013;8(1) doi: 10.1371/journal.pone.0053838. - DOI - PMC - PubMed
    1. Mckay S, Gaudier E, Campbell DI, Prentice AM, Albers R. Environmental enteropathy: new targets for nutritional interventions. Int Health. 2010;2(3):172–80. doi: 10.1016/j.inhe.2010.07.006. - DOI - PubMed

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