RecruitingNot ApplicableNCT04963777

Prebiotics in Patients With Type 1 Diabetes

Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes

Sponsor

University of Calgary

Enrollment

144 participants

Start Date

Mar 29, 2022

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

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.

Eligibility

Min Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether prebiotic supplements (special fibres that feed beneficial gut bacteria) can help preserve the body's own insulin production in people newly diagnosed with type 1 diabetes. **You may be eligible if...** - You have been diagnosed with type 1 diabetes within the past 12 months - At the main study site: you are 7 years or older - At other sites: you are between 7 and 17 years old **You may NOT be eligible if...** - You regularly take medications or supplements that affect gut bacteria (such as antibiotics, probiotics, laxatives) within the last 3 months - You have had intestinal surgery - You have another chronic condition affecting the gut (like Crohn's disease or ulcerative colitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPrebiotic

Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years)

DIETARY_SUPPLEMENTPlacebo

Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years)

Locations(3)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

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NCT04963777

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