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?

This trial explores whether prebiotic fiber can help manage type 1 diabetes by improving gut health and blood sugar control. Researchers compare a prebiotic supplement (oligofructose-enriched inulin, also known as Prebiotin) to a placebo to determine if it reduces the frequency of low blood sugar episodes over six months. It is open to individuals diagnosed with type 1 diabetes within the past year who do not regularly use medications affecting gut health. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in diabetes management.

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.

What prior data suggests that prebiotics are safe for individuals with type 1 diabetes?

Research has shown that prebiotics, such as oligofructose-enriched inulin, are generally safe for people with diabetes. In one small study involving children with type 1 diabetes, taking prebiotic fiber for three months did not cause any major safety issues. Another study found that this prebiotic improved blood sugar levels and overall health in women with type 2 diabetes. Although these studies examined different groups, the similar results suggest that prebiotics are safe and might even be beneficial. However, consulting a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for Type 1 Diabetes, which typically involves insulin therapy and blood sugar management, the prebiotic treatment uses oligofructose-enriched inulin to target gut health. Researchers are excited about this approach because it may influence the immune system and inflammation, potentially offering a new way to manage the condition from within the digestive system. This is a unique angle, as most current treatments focus directly on regulating blood sugar levels rather than modifying the gut microbiome.

What evidence suggests that prebiotics might be an effective treatment for type 1 diabetes?

Research has shown that prebiotic fiber might help manage type 1 diabetes (T1D). In a small study, children with T1D who took prebiotics for three months experienced fewer instances of low blood sugar. Prebiotics are believed to improve gut health, potentially aiding in blood sugar control. Another study found that prebiotics can increase certain immune cells in the pancreas, which might offer protection against T1D. Overall, early findings suggest that prebiotics could complement insulin treatment for better T1D management. In this trial, participants will receive either the prebiotic treatment, oligofructose-enriched inulin, or a placebo to evaluate its effectiveness in managing T1D. ^{1 4 6 7 8}

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Prebiotic supplementation in patients with type 1 diabetes In a pilot study, we showed that in children who had T1D for at least 1 year, a 3-month course of prebiotic fibre significantly reduced the frequency of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37947010/

Inulin prebiotic ameliorates type 1 diabetes dictating ... INU supplementation effectively protects against experimental T1D by recruiting CCR4+ regulatory T cells via CCL17 into the pancreas and altering the butyrate- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04963777

NCT04963777 | Prebiotics in Patients With Type 1 Diabetes Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714415301117

The effect of prebiotic supplementation with inulin on ... We hypothesize that prebiotic supplementation with inulin will improve insulin sensitivity and skeletal muscle metabolic flexibility. We will randomize 48 ...

5. academic.oup.com academic.oup.com/jcem/article/104/10/4427/5513497

Effect of Prebiotic on Microbiota, Intestinal Permeability, and ... Prebiotics are a potentially novel, inexpensive, low-risk treatment addition for T1D that may improve glycemic control. Further larger-scale ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4729356/

A Combination of Prebiotic Inulin and Oligofructose ... Conclusion: Oligofructose-enriched inulin may improve glycemic indices, lipid profile, antioxidant status and malondialdehyd in women with type 2 diabetes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02569684

Effects of Prebiotics on GLP-1 in Type 2 Diabetes The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000746

The Prebiotic Potential of Inulin-Type Fructans Beneficial health effects reported following ITF intake include improved intestinal barrier function, improved laxation, increased insulin sensitivity, ...