Prebiotics for Type 1 Diabetes

Recruiting at 2 trial locations

Overseen By Raylene A Reimer, PhD, RD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must be taking: Insulin

Must not be taking: Antibiotics, Probiotics, Prebiotics, Laxatives

Disqualifiers: Intestinal surgery, Crohn's, Celiac, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications or supplements that could affect gut bacteria, like antibiotics, probiotics, prebiotics, or laxatives, for at least 3 months before joining.

Is the prebiotic treatment safe for humans?

Prebiotics like oligofructose and inulin-type fructans have been studied in humans and animals, showing changes in gut bacteria and potential benefits for diabetes management. These studies suggest that prebiotics are generally safe, as they are non-digestible carbohydrates that help improve gut health. ^{1 2 3 4 5}

How does the prebiotic treatment for Type 1 Diabetes differ from other treatments?

This prebiotic treatment is unique because it focuses on altering the gut microbiota to improve insulin sensitivity and beta-cell function, which can help control blood sugar levels. Unlike traditional treatments that primarily focus on insulin replacement, this approach aims to enhance the body's natural insulin production and reduce inflammation by promoting beneficial gut bacteria. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Prebiotics for Type 1 Diabetes?

Research suggests that prebiotics like oligofructose can improve insulin sensitivity and beta-cell function in type 1 diabetes by altering gut bacteria, which may help control blood sugar levels. In studies with diabetic mice, adding oligofructose to treatment increased diabetes remission rates and improved insulin response. ^{1 3 5 8 9}

Who Is on the Research Team?

Raylene A Reimer, PhD, RD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with type 1 diabetes within the last year and are at least 8 years old. They must not be taking medications or supplements that affect gut bacteria, have had intestinal surgery, active infections, pregnancy, lactation, or other chronic conditions like Crohn's disease.

Inclusion Criteria

I was diagnosed with type 1 diabetes within the last year.

I am 8 years old or older and can do the needed tests.

Exclusion Criteria

I have a chronic condition like Crohn's, Celiac, colitis, or IBS.

I am not pregnant, breastfeeding, or have an active infection.

I have had surgery on my intestines before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month course of prebiotic or placebo as an adjunct to insulin

6 months

Regular visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Prebiotic

Trial Overview The study tests if prebiotic fiber can help manage blood sugar levels in people with new-onset type 1 diabetes by comparing a group taking prebiotics to another taking a placebo for six months as an addition to insulin therapy.

How Is the Trial Designed?

Group I: Prebiotic Experimental Treatment 1 Intervention

Oligofructose-enriched inulin

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

In a study with non-obese diabetic mice, the combination of the immunotherapy monoclonal anti-CD3 antibody (aCD3) and the prebiotic oligofructose (OFS) significantly increased the rate of diabetes remission compared to aCD3 alone after 8 weeks.

The addition of OFS improved insulin sensitivity, enhanced beta-cell function, and altered gut microbiota, suggesting that OFS could be a promising adjunctive therapy for type 1 diabetes by promoting better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oligofructose as an adjunct in treatment of diabetes in NOD mice. Chan, C., Hyslop, CM., Shrivastava, V., et al.[2022]

In a 12-week randomized, placebo-controlled trial involving 43 children with type 1 diabetes, prebiotic treatment led to a significant increase in C-peptide levels, suggesting improved insulin production, and a modest improvement in intestinal permeability.

The prebiotic group also showed a significant increase in beneficial gut bacteria (Bifidobacterium) compared to the placebo group, indicating that prebiotics may positively alter gut microbiota and potentially enhance glycemic control in children with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. Ho, J., Nicolucci, AC., Virtanen, H., et al.[2020]

This pilot study aims to assess the feasibility of a 12-week dietary intervention with prebiotics in children aged 8 to 17 years with type 1 diabetes, focusing on their potential to improve glycemic control by altering gut microbiota and intestinal permeability.

The study will evaluate various health measures, including insulin doses, frequency of hypoglycemia, and inflammatory markers, to determine if prebiotics can serve as a low-risk, cost-effective treatment option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial. Ho, J., Reimer, RA., Doulla, M., et al.[2018]

Probiotic supplementation significantly reduced fasting blood glucose levels in type 1 diabetes mellitus (T1DM) patients, with a decrease of about 31.24 mg/dL based on a meta-analysis of five randomized controlled trials involving 356 participants.

Despite the positive effect on fasting blood glucose, probiotics did not show significant improvements in other key measures like HbA1c, C-peptide, or insulin requirements, indicating that while they may help with blood sugar control, more research is needed to fully understand their role in T1DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics, prebiotics, and synbiotics in type 1 diabetes mellitus: A systematic review and meta-analysis of clinical trials. Moravejolahkami, AR., Shakibaei, M., Fairley, AM., et al.[2023]

Type 1 diabetes (T1D) is linked to dysbiosis, or abnormal gut microbiota, which can worsen the autoimmune response against pancreatic beta cells, particularly in individuals with multiple autoantibodies.

Using probiotics and prebiotics to restore gut microbiota balance has shown promise in reducing inflammation and improving gut integrity, suggesting a potential therapeutic avenue for managing T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics and Prebiotics for the Amelioration of Type 1 Diabetes: Present and Future Perspectives. Mishra, SP., Wang, S., Nagpal, R., et al.[2020]

In a study involving 29 adults with type 2 diabetes, prebiotic inulin-type fructans (ITF) did not significantly improve postprandial levels of glucagon-like peptide-1 (GLP-1) or glucose regulation compared to a control supplement (maltodextrin).

While the GLP-1 response showed a decline after ITF treatment, the control group experienced an increase, indicating that ITF may not enhance incretin responses in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. Birkeland, E., Gharagozlian, S., Gulseth, HL., et al.[2022]

A 6-week trial of a dietary supplement containing high-amylose maize-resistant starch modified with acetate and butyrate (HAMSAB) in adults with long-standing type 1 diabetes (T1D) showed increased levels of beneficial short-chain fatty acids (SCFAs) in stools and plasma, indicating a positive shift in gut microbiota composition.

While the supplement did not change glucose control or insulin requirements overall, participants with the highest SCFA levels experienced better glycemic control, suggesting that targeting dietary SCFAs could help improve immune profiles and promote better management of T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolite-based dietary supplementation in human type 1 diabetes is associated with microbiota and immune modulation. Bell, KJ., Saad, S., Tillett, BJ., et al.[2022]

In a study using a mouse model of type 1 diabetes (T1D), inulin (a prebiotic) was found to completely prevent the development of T1D in mice treated with streptozotocin (STZ), showing lower blood glucose levels and reduced pancreatic inflammation.

Inulin supplementation altered the gut microbiota, increasing beneficial bacteria and promoting the recruitment of specific regulatory T cells to the pancreas, which is crucial for immune regulation and protection against T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin prebiotic ameliorates type 1 diabetes dictating regulatory T cell homing via CCR4 to pancreatic islets and butyrogenic gut microbiota in murine model. Guimarães, JB., Rodrigues, VF., Pereira, ÍS., et al.[2023]

A pilot study involving 12 newly diagnosed youth with type 1 diabetes will assess the effects of high amylose maize starch (HAMS-AB) on gut microbiome changes, short chain fatty acid production, and β cell health, aiming to improve glycemia and immune responses.

Previous research indicates that HAMS-AB can prevent type 1 diabetes in rodent models without safety concerns, suggesting it may be a safe and effective dietary intervention for enhancing metabolic health in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. Ismail, HM., Spall, M., Evans-Molina, C., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Oligofructose as an adjunct in treatment of diabetes in NOD mice. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Probiotics, prebiotics, and synbiotics in type 1 diabetes mellitus: A systematic review and meta-analysis of clinical trials. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotics and Prebiotics for the Amelioration of Type 1 Diabetes: Present and Future Perspectives. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Metabolite-based dietary supplementation in human type 1 diabetes is associated with microbiota and immune modulation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Inulin prebiotic ameliorates type 1 diabetes dictating regulatory T cell homing via CCR4 to pancreatic islets and butyrogenic gut microbiota in murine model. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. [2023]