Prebiotics in Patients With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2027-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prebiotic Fiber Supplement in T1DM Children

NCT02442544

Type 1 Diabetes

UNKNOWN EARLY_PHASE1

Effects of Probiotics and Fibers on Albuminuria in Persons With Type 1 Diabetes

NCT04635670

Type 1 Diabetes Nephropathy Albuminuria +1 more

COMPLETED NA

Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes

NCT04579341

Diabetes Mellitus, Type 1

UNKNOWN NA

Lactobacillus Johnsonii Supplementation in Adults With T1D

NCT03961347

Type 1 Diabetes (T1D)

ACTIVE_NOT_RECRUITING PHASE2

Effect of Probiotics on Pre-diabetes and Diabetes in China

NCT03377946

Type 2 Diabetes Mellitus

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centre placebo controlled double-blind randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The prebiotic and placebo are both white powders with similar sweet taste and dissolve in water.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prebiotic

Oligofructose-enriched inulin

Group Type EXPERIMENTAL

Prebiotic

Intervention Type 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)

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prebiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No