Effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: protocol of a randomised controlled trial

BMJ Open. 2017 Oct 11;7(10):e017178. doi: 10.1136/bmjopen-2017-017178.

Abstract

Introduction: Recent evidence has demonstrated that, among other factors, dysbiosis (imbalances in the composition and function of the gut microbiota) may be relevant in the development of type 1 diabetes (T1D). Thus, gut microbiota may be a target for improving outcomes in subjects with T1D. The aim of the study is to examine the effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed T1D.

Methods and analysis: A total of 96 children aged 8 to 17 years with newly diagnosed T1D, confirmed by clinical history and the presence of at least one positive autoantibody, will be enrolled in a double-blind, randomised, placebo-controlled trial in which they will receive L. rhamnosus GG and B. lactis Bb12 at a dose of 109 colony-forming units or an identically appearing placebo, orally, once daily, for 6 months. The follow-up will be for 12 months. The primary outcome measures will be the area under the curve of the C-peptide level during 2-hour responses to a mixed meal.

Ethics and dissemination: The Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences.

Trial registration number: NCT03032354; Pre-results.

Keywords: RCT; children; microbiota; probiotics.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Area Under Curve
  • Bifidobacterium animalis*
  • C-Peptide / blood*
  • Child
  • Clinical Protocols
  • Diabetes Mellitus, Type 1* / etiology
  • Diabetes Mellitus, Type 1* / immunology
  • Diabetes Mellitus, Type 1* / therapy
  • Double-Blind Method
  • Dysbiosis / therapy
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Insulin-Secreting Cells*
  • Lactobacillus rhamnosus*
  • Male
  • Probiotics / administration & dosage*

Substances

  • C-Peptide

Associated data

  • ClinicalTrials.gov/NCT03032354