Using prebiotics to improve glycemic control in type 1 diabetes
Official title: Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
Run by University of Calgary · NCT04963777 · Data updated 2026-11-12
This study is testing whether taking prebiotics can help people with type 1 diabetes better manage their blood sugar levels while they continue their insulin therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 3 sites (Calgary, Alberta and 2 other locations) |
| Status | Recruiting |
| Started | March 29, 2022 |
| Main results expected | December 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT04963777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 7 years and older who have been diagnosed with type 1 diabetes within the last 12 months.
✕Probably not a fit
Patients with chronic gastrointestinal conditions or those on medications that affect gut microbiota may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of prebiotic supplementation on glycemic control in individuals with type 1 diabetes. Participants will receive either prebiotics or a placebo for six months alongside their insulin therapy. The study aims to assess changes in the frequency of hypoglycemia, glycemic variability, and gut microbiota composition, as well as other metabolic and inflammatory markers. By understanding the mechanisms through which prebiotics may influence glucose regulation, the trial seeks to provide insights into potential adjunct therapies for managing type 1 diabetes.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and reduced hypoglycemia in patients with type 1 diabetes.
How similar studies have gone: While the use of prebiotics in diabetes management is an emerging area, previous studies have shown promising results in improving gut health and metabolic outcomes, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of Calgary
Calgary, Alberta, Canada Recruiting -
University of Alberta
Edmonton, Alberta, Canada Recruiting -
University of Saskatchewan
Saskatoon, Saskatchewan, Canada Recruiting
Study contacts
- Principal investigator: Raylene A Reimer, PhD, RD — University of Calgary
- Study coordinator: Raylene A Reimer, PhD, RD
- Email: reimer@ucalgary.ca
- Phone: 403-220-8218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.