Prebiotics in Patients With Type 1 Diabetes
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT04963777
- Run by
- University of Calgary
- People needed
- 144
- Starts
- 2022-03-29
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 7 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Calgary — Calgary, Alberta, Canada (enrolling)
- University of Alberta — Edmonton, Alberta, Canada (enrolling)
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (enrolling)
Full record on ClinicalTrials.gov
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