Type 1 DiabetesNCT04963777
Prebiotics in Patients With Type 1 Diabetes
A study testing Prebiotic in people with Type 1 Diabetes, run by University of Calgary at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 3 sitesCanada
- Study dates
- 29 Mar 2022to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Raylene A Reimer, PhD, RD, 403-220-8218, reimer@ucalgary.ca
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 1C9
Elizabeth Rosolowsky, MD, MPH, 780-248-5483, Elizabeth.Rosolowsky@albertahealthservices.ca
Elizabeth Rosolowsky, MD, MPH
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5E5
Munier Nour, MD, MSc, 306-655-2048, munier.nour@usask.ca
Munier Nour, MD, MSc
About this study
Official title: Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
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
- 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.
- To compare the change in stimulated C-peptide and pro-insulin from baseline to 6 months.
- To determine the change in IP from baseline to 6 months.
- To determine the change in serum inflammatory markers (IL-6, IFN-gamma, TNF, C-reactive protein, and IL-10).
- To examine quality of life (QOL) and fear of hypoglycemia ratings, and adverse reactions (severe hypoglycemia, diabetic ketoacidosis, side effects).
- To examine prebiotic-induced changes in gut microbiota composition and function (shotgun sequencing) and their metabolic by-products (fecal and serum metabolomics).
- To compare the change in frequency of hypoglycemia from baseline to 9 months to determine persistence of effects post-intervention.
- To determine the change in glycemic variability from baseline to 9 months to determine persistence of effects post-intervention.
- Conditions
- Type 1 Diabetes
- Being tested
- Prebiotic, Placebo
- Keywords
- Gut microbiota, Glycemic control, Prebiotic, Oligofructose-enriched inulin, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years)
PlaceboDietary supplement
Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years)
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Oligofructose-enriched inulin Receives: Dietary Supplement: Prebiotic |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of hypoglycemia
Blood glucose <3.9 mmol/L from continuous glucose monitor data
Measured: 6 months
Secondary outcomes (20)
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.
Measured: 6 months
Change in glycemic control
Glycated hemoglobin (A1C)
Measured: 6 months
Change in stimulated C-peptide
Serum collected during a mixed meal tolerance test
Measured: 6 months
Change in serum proinsulin
Serum collected during a mixed meal tolerance test
Measured: 6 months
Change in Intestinal permeability
Urinary lactulose/mannitol test
Measured: 6 months
Change in lipopolysaccharide
Serum lipopolysaccharide concentration
Measured: 6 months
Change in Inflammatory marker IL-6
Serum IL-6
Measured: 6 months
Change in Inflammatory marker IFN-γ
Serum IFN-γ
Measured: 6 months
Change in Inflammatory marker TNF
Serum TNF
Measured: 6 months
Change in Inflammatory marker CRP
Serum CRP
Measured: 6 months
Change in Inflammatory marker IL-10
Serum IL-10
Measured: 6 months
Change in quality of life
Diabetes-specific quality of life survey
Measured: 6 months
Change in fear of hypoglycemia
Fear of hypoglycemia ratings survey
Measured: 6 months
Change in gut microbiota composition
Fecal microbiota taxonomy
Measured: 6 months
Change in gut microbiota function
Fecal microbiota shotgun sequencing
Measured: 6 months
Change in serum metabolite concentration
Serum LC-Qtof-Mass Spec metabolomics
Measured: 6 months
Change in fecal metabolite concentrations
Serum LC-Qtof-Mass Spec metabolomics
Measured: 6 months
Change in frequency of hypoglycemia post-intervention
Blood glucose <3.9 mmol/L from continuous glucose monitor data
Measured: 9 months
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.
Measured: 9 months
Change in glycemic control post-intervention
Glycated hemoglobin (A1C)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start29 Mar 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre placebo controlled double-blind randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Raylene Reimer, University of Calgary
- Investigators
- Raylene A Reimer, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963777
- Sponsor's protocol ID
- REB21-0852
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data will be available from the corresponding author upon reasonable request.
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04963777
- Acronym / sponsor ID
- REB21-0852
- Conditions
- Type 1 Diabetes
- Keywords
- Gut microbiota, Glycemic control, Prebiotic, Oligofructose-enriched inulin, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- To compare the change in stimulated C-peptide and pro-insulin from baseline to 6 months.
- To determine the change in IP from baseline to 6 months.
- To determine the change in serum inflammatory markers (IL-6, IFN-gamma, TNF, C-reactive protein, and IL-10).
- To examine quality of life (QOL) and fear of hypoglycemia ratings, and adverse reactions (severe hypoglycemia, diabetic ketoacidosis, side effects).
- To examine prebiotic-induced changes in gut microbiota composition and function (shotgun sequencing) and their metabolic by-products (fecal and serum metabolomics).
- To compare the change in frequency of hypoglycemia from baseline to 9 months to determine persistence of effects post-intervention.
- To determine the change in glycemic variability from baseline to 9 months to determine persistence of effects post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre placebo controlled double-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: PrebioticOligofructose-enriched inulin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticChicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years) | Dietary supplement | Prebiotic |
| PlaceboMaltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years) | Dietary supplement | Placebo |
Primary outcome
Change in frequency of hypoglycemia
Time frame: 6 months
Blood glucose <3.9 mmol/L from continuous glucose monitor data
20 secondary outcomes
Change in glycemic variability
Time frame: 6 months
Change in glycemic control
Time frame: 6 months
Change in stimulated C-peptide
Time frame: 6 months
Change in serum proinsulin
Time frame: 6 months
Change in Intestinal permeability
Time frame: 6 months
Change in lipopolysaccharide
Time frame: 6 months
Change in Inflammatory marker IL-6
Time frame: 6 months
Change in Inflammatory marker IFN-γ
Time frame: 6 months
Change in Inflammatory marker TNF
Time frame: 6 months
Change in Inflammatory marker CRP
Time frame: 6 months
Change in Inflammatory marker IL-10
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Change in fear of hypoglycemia
Time frame: 6 months
Change in gut microbiota composition
Time frame: 6 months
Change in gut microbiota function
Time frame: 6 months
Change in serum metabolite concentration
Time frame: 6 months
Change in fecal metabolite concentrations
Time frame: 6 months
Change in frequency of hypoglycemia post-intervention
Time frame: 9 months
Change in glycemic variability post-intervention
Time frame: 9 months
Change in glycemic control post-intervention
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 40449951Huang 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.
- Individual participant dataSharing planned: No. De-identified participant data will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raylene A Reimer, PhD, RD principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Type 1 Diabetes, run by University of Calgary at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raylene A Reimer, PhD, RD (403-220-8218, reimer@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of hypoglycemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.