Probiotics for Type 1 Diabetes

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must not be taking: Probiotics, Immunomodulatory agents

Disqualifiers: Severe active disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how probiotics might help manage Type 1 diabetes (T1D) by balancing gut bacteria. Researchers believe gut imbalances could worsen T1D and aim to determine if probiotics can improve this condition. Participants will receive either Visbiome, a probiotic treatment, or a placebo (a harmless pill with no active ingredients) to compare effects. The trial seeks young people, ages 5-17, diagnosed with T1D in the last 90 days and possessing certain diabetes-related antibodies. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in T1D management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used probiotics within 1 month before the screening. If you have a severe, active disease that requires chronic medication, you may not be eligible, except for well-controlled autoimmune thyroiditis/hypothyroidism.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that Visbiome, the probiotic used in the study, is generally well-tolerated. Studies have found that participants usually take it without problems, and no negative side effects have been reported. With over 70 published, peer-reviewed, controlled trials, Visbiome ranks among the most researched probiotics available. This extensive research suggests that Visbiome is safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 diabetes?

Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin therapy, Visbiome is a probiotic formulation that introduces beneficial bacteria to the gut. This new approach is exciting because it may help modulate the immune system, potentially reducing the autoimmune attack on insulin-producing cells. Researchers are particularly interested in Visbiome's ability to provide a natural, gut-focused strategy that could complement or even enhance traditional diabetes management.

What evidence suggests that this treatment might be an effective treatment for Type 1 diabetes?

Studies have shown that Visbiome, a potent probiotic with multiple strains, can help individuals with Type 1 Diabetes manage blood sugar levels more effectively. In children recently diagnosed with Type 1 Diabetes, those who took probiotics alongside their usual treatments achieved better blood sugar control and required less insulin. Another study found that probiotics significantly lowered fasting blood sugar levels by about 31.24 mg/dL. This trial will evaluate Visbiome as an experimental treatment, while another group will receive a placebo. These findings suggest that altering gut bacteria with probiotics like Visbiome might enhance the overall health of people with Type 1 Diabetes. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 5-17 who were diagnosed with Type 1 diabetes in the last 90 days, have certain autoantibodies, haven't used immunomodulatory drugs, and show a specific level of insulin production. It's not for those on chronic meds (except controlled thyroid issues), pregnant teens, or recent probiotic users.

Inclusion Criteria

Your body produces a certain amount of a substance called C-peptide after eating a meal. If the amount is higher than a certain level, you may not be able to participate in the study.

I have tested positive for diabetes-related autoantibodies.

I have not received any immune system modifying treatments.

Exclusion Criteria

I am not pregnant and can have children.

Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

I have diabetes, but it's not Type 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multistrain probiotic or placebo to assess its impact on inflammation and intestinal microbiota

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visbiome

Trial Overview

The study tests if Visbiome, a probiotic, can positively affect gut bacteria and potentially slow down Type 1 diabetes progression after diagnosis. Participants will be randomly given either Visbiome or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Group II: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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 involving 96 children aged 8-17 with newly diagnosed type 1 diabetes, the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 did not significantly improve beta-cell function compared to a placebo over a 6-month period.

While there were no severe adverse effects reported, the probiotic group showed a higher incidence of thyroid autoimmunity, although this was also present at baseline, indicating the need for further research to determine the safety and efficacy of these probiotics in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial. Groele, L., Szajewska, H., Szalecki, M., et al.[2022]

The study will involve 96 children aged 8 to 17 with newly diagnosed type 1 diabetes, testing the effects of probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function over 6 months.

The primary outcome will measure changes in C-peptide levels after meals, which is crucial for assessing insulin production and beta-cell function in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: protocol of a randomised controlled trial. Groele, L., Szajewska, H., Szypowska, A.[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]

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The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

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A high potency multi‐strain probiotic improves glycemic ...

Children with newly diagnosed T1DM managed with standard treatment along with probiotics showed better glycemic control and a decrease in insulin requirements.

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Probiotics for Type 1 Diabetes · Info for Participants

Probiotic supplementation significantly reduced fasting blood glucose levels in type 1 diabetes mellitus (T1DM) patients, with a decrease of about 31.24 mg/dL ...

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Probiotic therapy with Visbiome® may improve the fasting glucose and possibly decrease the gut microbial F/B ratio as compared to placebo in adolescents with ...

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New Product Announcements

With more than 70 published, peer reviewed, controlled trials, Visbiome® remains one of the most widely studied probiotics available on the market. Our 8-strain ...

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Probiotics in Newly Diagnosed T1D - ClinicalTrials.Veeva

Patients must meet all of the following criteria: Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days ...