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RecruitingNCT04963777Updated May 1, 2026

Prebiotics in Patients With Type 1 Diabetes

An interventional study of Prebiotic and Placebo in Type 1 Diabetes, sponsored by University of Calgary. Recruiting at 3 sites in Canada. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
7 Years and older
Sex
All
01

Study 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.

Read the detailed description

The investigators hypothesize that, as an adjunct to insulin, prebiotic supplementation will reduce the frequency of hypoglycemia and improve glycemic variability that is accompanied by enhanced serum C-peptide levels, a reduction in intestinal permeability and systemic inflammation, and altered gut microbiota.

Primary Objective To compare the change in frequency of hypoglycemia from baseline to 6 months in individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin.

Secondary Objectives

  1. To determine the change in glycemic variability and glycemic control using Continuous Glucose Monitor (CGM) metrics including: percentage change in Time In-, Below-, and Above-Range (i.e. TIR, TBR, and TAR) and A1C from baseline to 6 months in those treated with prebiotic or placebo.
  2. To compare the change in stimulated C-peptide and pro-insulin from baseline to 6 months.
  3. To determine the change in IP from baseline to 6 months.
  4. To determine the change in serum inflammatory markers (IL-6, IFN-gamma, TNF, C-reactive protein, and IL-10).
  5. To examine quality of life (QOL) and fear of hypoglycemia ratings, and adverse reactions (severe hypoglycemia, diabetic ketoacidosis, side effects).
  6. To examine prebiotic-induced changes in gut microbiota composition and function (shotgun sequencing) and their metabolic by-products (fecal and serum metabolomics).
  7. To compare the change in frequency of hypoglycemia from baseline to 9 months to determine persistence of effects post-intervention.
  8. To determine the change in glycemic variability from baseline to 9 months to determine persistence of effects post-intervention.
02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Gut microbiota
  • Glycemic control
  • Prebiotic
  • Oligofructose-enriched inulin
  • Hypoglycemia
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 144 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Browse University of Calgary studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Prebiotic

    Oligofructose-enriched inulin

    Dietary Supplement: Prebiotic

  • Placebo comparator
    Placebo

    Maltodextrin

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPrebiotic

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change in frequency of hypoglycemia

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

    Time frame: 6 months

Secondary outcomes

  1. Change in glycemic variability

    CGM-recorded composite of percentage of 'time-in-range" (glucose of 3.9-10 mmol/L), "time-below-range" as mild (glucose 3.0-3.9 mmol/L) or moderate (glucose \<3.0 mmol/L) hypoglycemia, and "time-above- range" as moderate (glucose 10.1-13.9 mmol/L) and severe (glucose \>13.9 mmol/L) hyperglycemia.

    Time frame: 6 months

  2. Change in glycemic control

    Glycated hemoglobin (A1C)

    Time frame: 6 months

  3. Change in stimulated C-peptide

    Serum collected during a mixed meal tolerance test

    Time frame: 6 months

  4. Change in serum proinsulin

    Serum collected during a mixed meal tolerance test

    Time frame: 6 months

  5. Change in Intestinal permeability

    Urinary lactulose/mannitol test

    Time frame: 6 months

  6. Change in lipopolysaccharide

    Serum lipopolysaccharide concentration

    Time frame: 6 months

  7. Change in Inflammatory marker IL-6

    Serum IL-6

    Time frame: 6 months

  8. Change in Inflammatory marker IFN-γ

    Serum IFN-γ

    Time frame: 6 months

  9. Change in Inflammatory marker TNF

    Serum TNF

    Time frame: 6 months

  10. Change in Inflammatory marker CRP

    Serum CRP

    Time frame: 6 months

  11. Change in Inflammatory marker IL-10

    Serum IL-10

    Time frame: 6 months

  12. Change in quality of life

    Diabetes-specific quality of life survey

    Time frame: 6 months

  13. Change in fear of hypoglycemia

    Fear of hypoglycemia ratings survey

    Time frame: 6 months

  14. Change in gut microbiota composition

    Fecal microbiota taxonomy

    Time frame: 6 months

  15. Change in gut microbiota function

    Fecal microbiota shotgun sequencing

    Time frame: 6 months

  16. Change in serum metabolite concentration

    Serum LC-Qtof-Mass Spec metabolomics

    Time frame: 6 months

  17. Change in fecal metabolite concentrations

    Serum LC-Qtof-Mass Spec metabolomics

    Time frame: 6 months

  18. Change in frequency of hypoglycemia post-intervention

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

    Time frame: 9 months

  19. Change in glycemic variability post-intervention

    CGM-recorded composite of percentage of 'time-in-range" (glucose of 3.9-10 mmol/L), "time-below-range" as mild (glucose 3.0-3.9 mmol/L) or moderate (glucose \<3.0 mmol/L) hypoglycemia, and "time-above- range" as moderate (glucose 10.1-13.9 mmol/L) and severe (glucose \>13.9 mmol/L) hyperglycemia.

    Time frame: 9 months

  20. Change in glycemic control post-intervention

    Glycated hemoglobin (A1C)

    Time frame: 9 months

Other outcomes

  1. Change in dietary intake

    24 hour dietary recall (energy intake, kcal)

    Time frame: 6 months

  2. Change in dietary intake

    24 hour dietary recall (fat intake, grams)

    Time frame: 6 months

  3. Change in dietary intake

    24 hour dietary recall (carbohydrate intake, grams)

    Time frame: 6 months

  4. Change in dietary intake

    24 hour dietary recall (protein intake, grams)

    Time frame: 6 months

  5. Change in dietary intake

    24 hour dietary recall (fiber intake, grams)

    Time frame: 6 months

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • 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. PubMed 40449951 ↗

Individual participant data

Plan to share: No — De-identified participant data will be available from the corresponding author upon reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04963777
Lead sponsor
University of Calgary
Responsible party
Dr. Raylene Reimer (Professor, University of Calgary) — Principal investigator
First posted
Jul 15, 2021
Start date
Mar 29, 2022
Primary completion
Dec 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
May 1, 2026

Study contacts

Raylene A Reimer, PhD, RD
Contact
reimer@ucalgary.ca
403-220-8218
Raylene A Reimer, PhD, RD
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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