NCT04963777Recruiting
Prebiotics in Patients With Type 1 Diabetes
Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 12 Jul 2021
- Start date
- 29 Mar 2022
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- University of Calgary
- Diseases
- Type 1 diabetes
- NCT number
- NCT04963777
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 29 Mar 2022 to the primary completion date, 1 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.