NCT04963777 Prebiotics in Patients With Type 1 Diabetes
| NCT ID | NCT04963777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2022-03-29 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2022-03-29 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Raylene A Reimer, PhD, RD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT04963777 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04963777 currently recruiting?
Yes, NCT04963777 is actively recruiting participants. Contact the research team at reimer@ucalgary.ca for enrollment information.
Where is the NCT04963777 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Saskatoon, Canada.
Who is sponsoring the NCT04963777 clinical trial?
NCT04963777 is sponsored by University of Calgary. The principal investigator is Raylene A Reimer, PhD, RD at University of Calgary. The trial plans to enroll 144 participants.
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