The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial

Zainab Alyousif, Jennifer L Miller, Mariana Y Sandoval, Chad W MacPherson, Varuni Nagulesapillai, Wendy J Dahl, Zainab Alyousif, Jennifer L Miller, Mariana Y Sandoval, Chad W MacPherson, Varuni Nagulesapillai, Wendy J Dahl

Abstract

Background: Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome.

Methods: Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses.

Discussion: To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation.

Trial registration: ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.

Keywords: Bifidobacterium; Prader–Willi syndrome; constipation; gastrointestinal function; microbiome.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the University of Florida’s Institutional Review Board 1 (IRB-1) on 19 September 2017 protocol #IRB201701976. Approval will be sought through the IRB-1 for any future revisions to the protocol and will be updated at clinicaltrials.gov. All subjects will be interviewed and provide written informed consent to participate in this study.

Competing interests

The authors ZA, WJD, and JLM declare that they have no competing interests. MS, CM, and VN are employed by Lallemand Health Solutions, the sponsor of this investigation.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study Design (DQ daily questionnaire, GSRS Gastrointestinal Symptom Rating Scale, B. lactis B94 Bifidobacterium animalis ssp. lactis B94)
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments as per Standard Protocol Items: Recommendations for Interventional trials (SPIRIT)

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