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

43 Participants Needed

Trial Summary

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.

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

Research suggests that probiotics, like those in Visbiome, may help reduce inflammation, which is linked to Type 1 Diabetes. A study showed that probiotics could lower inflammation in siblings of Type 1 Diabetes patients, indicating potential benefits for managing the condition. ^{1 2 3 4 5}

Is the probiotic treatment safe for humans?

Probiotic supplementation, including products like Visbiome, has been well-tolerated in studies, with high participant adherence and no reported adverse events, suggesting it is generally safe for human use. ^{1 2 3 4 5}

How does the treatment Visbiome differ from other treatments for type 1 diabetes?

Visbiome is a probiotic treatment that aims to improve gut health and reduce inflammation, which may help manage type 1 diabetes by addressing gut microbiota imbalances. Unlike traditional treatments that focus on insulin regulation, Visbiome targets the gut environment to potentially modify disease progression. ^{1 2 3 6 7}

What is the purpose of this trial?

This trial is testing whether taking probiotics can help people with Type 1 diabetes by improving their gut health and reducing inflammation. Previous studies have shown that probiotics can reduce inflammation and improve gut health in both animals and humans with Type 1 diabetes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Probiotic normalization of systemic inflammation in siblings of type 1 diabetes patients: an open-label pilot study. [2022]

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

Oral Probiotic VSL#3 Prevents Autoimmune Diabetes by Modulating Microbiota and Promoting Indoleamine 2,3-Dioxygenase-Enriched Tolerogenic Intestinal Environment. [2019]

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

Transplantation of Fecal Microbiota Shaped by Diet. [2022]

5. England 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. [2022]

6. 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]

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

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