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- Title
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.
- Authors
Josephine Ho; Reimer, Raylene A.; Doulla, Manpreet; Huang, Carol; Ho, Josephine
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov: NCT02442544 . Registered on 10 March 2015.
- Subjects
ALBERTA; TREATMENT of diabetes; TYPE 1 diabetes; PREBIOTICS; GLYCEMIC control; INTESTINAL physiology; MEMBRANE permeability (Biology); GUT microbiome; CHILDREN'S health; THERAPEUTICS; AGE distribution; BLOOD sugar; COMPARATIVE studies; EXPERIMENTAL design; GLUCANS; INTESTINES; OLIGOSACCHARIDES; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; PERMEABILITY; RESEARCH; TIME; PILOT projects; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; DIAGNOSIS
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1486-y