Prebiotic Fibre Tested Alongside Insulin in Type 1 Diabetes
Tests a prebiotic fibre against placebo, added to insulin, in people with type 1 diabetes.
Key facts
- Who runs it
- University of Calgary
- Where
- Calgary, Edmonton, and Saskatoon, CanadaSee the 3 sites
- Trial code
- Registry title
- Prebiotics in Patients With Type 1 Diabetes
- Status
- Recruiting
- People taking part
- 144 people, planned
- Started
- 29 Mar 2022
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Prebiotic
- Placebo
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with type 1 diabetes diagnosed in the past 12 months. It tests a prebiotic fibre supplement against a placebo, added to insulin, for 6 months.
- Age
- 7 years and older at the lead site; 7 to 17 years at the other sites.
- Sex
- Males and females can join.
- Disease stage
- Type 1 diabetes diagnosed in the previous 12 months, based on the Diabetes Canada 2018 Clinical Practice Guideline criteria.
- Earlier treatment
- No regular use of antibiotics, probiotic or prebiotic supplements, laxatives or other medicines or supplements that could affect gut bacteria in the 3 months before enrollment. No previous intestinal surgery.
Main reasons for not taking part
- Regular use of medicines or supplements that could affect gut bacteria within 3 months before enrollment
- Previous intestinal surgery
- Another long-term condition that could affect gut bacteria or the gut lining, such as Crohn's disease, Celiac disease, colitis or irritable bowel syndrome
- Active infection
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Canada
- University Of CalgaryCalgary, CanadaContact: Raylene A Reimer, PhD, RDTaking people
- University of AlbertaEdmonton, CanadaContact: Elizabeth Rosolowsky, MD, MPHTaking people
- University of SaskatchewanSaskatoon, CanadaContact: Munier Nour, MD, MScTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- PrebioticTreatment being tested
Oligofructose-enriched inulin
- PlaceboPlacebo, for comparison
Maltodextrin
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
- Plain-language title
- Prebiotic Fibre Tested Alongside Insulin in Type 1 DiabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 May 2026