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Prebiotics in Patients With Type 1 Diabetes

RecruitingNAAges 7 Years - anyAllUniversity of Calgary
NCT04963777 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hyper- and hypoglycemia in type 1 diabetes (T1D). The primary objective is to compare the change in frequency of hypoglycemia from baseline to 6 months in n=144 individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin. Secondary objectives will be aimed at understanding the mechanisms by which the prebiotics could affect glycemic control.

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📋 Eligibility rules (as published)
Inclusion Criteria: Lead Site: * Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months. * Age 7 years and above (as per our pilot trial and able to complete the required tests). Subsites: * Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months. * Age 7 to 17 years of age. Exclusion Criteria: * Regular use of medications or supplements that could affect gut microbiota (examples: antibiotics, probiotic or prebiotic supplements, laxatives) within 3 months prior to enrollment. * Previous intestinal surgery. * Another chronic medical condition that could affect gut microbiota or intestinal permeability (examples: Crohn's disease, Celiac disease, colitis, irritable bowel syndrome) * Presence of active infection, pregnancy or lactation.
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What it tests

  • Prebiotic
  • Placebo
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Where

3 sites
University of Calgary
Calgary, Canada
University of Alberta
Edmonton, Canada
University of Saskatchewan
Saskatoon, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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