Recruiting

Prebiotics

Sponsor:

University of Calgary

Code:

NCT04963777

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Prebiotic

Placebo

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT04963777

Start date

Mar 29, 2022

Status verified date

Apr, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prebiotic

Oligofructose-enriched inulin

placebo comparator: Placebo

Maltodextrin

Interventions

Prebiotic

Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years)

Placebo

Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years)

Primary outcome measure

  • Change in frequency of hypoglycemia [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Raylene A Reimer, PhD, RD

403-220-8218reimer@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Raylene A Reimer, PhD, RD

403-220-8218reimer@ucalgary.ca

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

Contacts

Elizabeth Rosolowsky, MD, MPH

780-248-5483Elizabeth.Rosolowsky@albertahealthservices.ca

Principal Investigator:

Elizabeth Rosolowsky, MD, MPH

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5E5

Contacts

Munier Nour, MD, MSc

306-655-2048munier.nour@usask.ca

Principal Investigator:

Munier Nour, MD, MSc

More Information

Sponsor

University of Calgary

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Gut microbiota
  • Glycemic control
  • Prebiotic
  • Oligofructose-enriched inulin
  • Hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-01.