Actively Recruiting
Prebiotics in Patients With Type 1 Diabetes
Led by University of Calgary · Updated on 2026-05-01
144
Participants Needed
3
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prebiotics in Patients With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
2
University of Alberta
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
3
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5E5
Actively Recruiting
Research Team
R
Raylene A Reimer, PhD, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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