Effect of Prebiotic Intake on Gut Microbiota, Intestinal Permeability and Glycemic Control in Children With Type 1 Diabetes: Study Protocol for a Randomized Controlled Trial

Trials. 2016 Jul 26;17(1):347. doi: 10.1186/s13063-016-1486-y.


Background: The gut microbiome is increasingly recognized as a contributor to disease states. Patients with type 1 diabetes (DM1) have distinct gut microbiota in comparison to non-diabetic individuals, and it has been linked to changes in intestinal permeability, inflammation and insulin resistance. Prebiotics are non-digestible carbohydrates that alter gut microbiota and could potentially improve glycemic control in children with DM1. This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotics in children with DM1.

Methods/design: This pilot study is a single-centre, randomized, double-blind, placebo-controlled trial in children aged 8 to 17 years with DM1 for at least one year. Participants will be randomized to receive either placebo (maltodextrin 3.3 g orally/day) or prebiotics (oligofructose-enriched inulin 8 g orally/day; Synergy1, Beneo, Mannheim, Germany). Measures to be assessed at baseline, 3 months and 6 months include: anthropometric measures, insulin doses/regimens, frequency of diabetic ketoacidosis, frequency of severe hypoglycemia, average number of episodes of hypoglycemia per week, serum C-peptide, HbA1c, serum inflammatory markers (IL-6, IFN-gamma, TNF-alpha, and IL-10), GLP-1 and GLP-2, intestinal permeability using urine assessment after ingestion of lactulose, mannitol and 3-O-methylglucose, and stool sample collection for gut microbiota profiling.

Discussion: This is a novel pilot study designed to test feasibility for a fully powered study. We hypothesize that consumption of prebiotics will alter gut microbiota and intestinal permeability, leading to improved glycemic control. Prebiotics are a potentially novel, inexpensive, low-risk treatment addition for DM1 that may improve glycemic control by changes in gut microbiota, gut permeability and inflammation.

Trial registration: ClinicalTrials.gov: NCT02442544 . Registered on 10 March 2015.

Keywords: Child; Gut microbiota; Intestinal permeability; Prebiotics; Type 1 diabetes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Age Factors
  • Alberta
  • Biomarkers / blood
  • Blood Glucose / metabolism*
  • Child
  • Clinical Protocols
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis
  • Diabetes Mellitus, Type 1 / microbiology
  • Diabetes Mellitus, Type 1 / therapy*
  • Double-Blind Method
  • Feasibility Studies
  • Female
  • Gastrointestinal Microbiome*
  • Humans
  • Intestinal Mucosa / metabolism
  • Intestines / microbiology*
  • Inulin / administration & dosage*
  • Inulin / adverse effects
  • Male
  • Oligosaccharides / administration & dosage*
  • Oligosaccharides / adverse effects
  • Permeability
  • Pilot Projects
  • Prebiotics / administration & dosage*
  • Prebiotics / adverse effects
  • Research Design
  • Time Factors
  • Treatment Outcome


  • Biomarkers
  • Blood Glucose
  • Oligosaccharides
  • Prebiotics
  • oligofructose
  • Inulin

Associated data

  • ClinicalTrials.gov/NCT02442544