Prebiotic Fibre Tested Alongside Insulin in Type 1 Diabetes
Tests a prebiotic fibre against placebo, added to insulin, in people with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Prebiotics in Patients With Type 1 Diabetes
Key facts
- Where
- Calgary, Edmonton, and Saskatoon, CanadaSee the 3 sites
Where in Canada
- University Of CalgaryCalgary, CanadaTaking people
- University of AlbertaEdmonton, CanadaTaking people
- University of SaskatchewanSaskatoon, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT04963777
- Record updated
- 1 May 2026
- Original description
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.Read full original descriptionShow less
Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
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.
Inclusion: 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: 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.