Prebiotics in Patients With Type 1 Diabetes

NCT04963777 | Recruiting

• 1 other identifier: REB21-0852
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in frequency of hypoglycemia

  Blood glucose \<3.9 mmol/L from continuous glucose monitor data

  6 months

Secondary Outcomes (20)

• Change in glycemic variability

  6 months

• Change in glycemic control

  6 months

• Change in stimulated C-peptide

  6 months

• Change in serum proinsulin

  6 months

• Change in Intestinal permeability

  6 months

Other Outcomes (5)

• Change in dietary intake

  6 months

• Change in dietary intake

  6 months

• Change in dietary intake

  6 months

Study Arms (2)

Prebiotic

EXPERIMENTAL

Oligofructose-enriched inulin

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Prebiotic DIETARY_SUPPLEMENT

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

Prebiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

RECRUITING

Related Publications (1)

• Huang C, Rosolowsky E, Nour MA, Butalia S, Ho J, Mayengbam S, Wang W, Pyke S, Virtanen H, Reimer RA. Prebiotic supplementation in patients with type 1 diabetes: study protocol for a randomised controlled trial in Canada. BMJ Open. 2025 May 31;15(5):e102486. doi: 10.1136/bmjopen-2025-102486.

  PMID: 40449951 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Raylene A Reimer, PhD, RD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raylene A Reimer, PhD, RD

CONTACT

403-220-8218; reimer@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The prebiotic and placebo are both white powders with similar sweet taste and dissolve in water.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-centre placebo controlled double-blind randomized clinical trial

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: March 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)