What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, dietary management, and blood sugar monitoring. Insulin therapy can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. Probiotics, which are being studied for their potential to alter intestinal microbiota composition in T1D, generally have mild side effects like bloating, gas, and digestive discomfort. However, more research is needed to fully understand their impact on T1D management.

What prior FDA approvals exist?

The primary FDA-approved treatments for Type 1 Diabetes (T1D) focus on insulin therapy, including rapid-acting, long-acting, and intermediate-acting insulins. Examples include insulin lispro, insulin glargine, and insulin NPH. While these treatments are essential for managing blood glucose levels, there are no FDA-approved treatments specifically involving probiotics or altering intestinal microbiota composition for T1D. Current research, such as the trial on probiotics, aims to explore new avenues by potentially modifying gut microbiota to influence the disease trajectory, but these approaches are still under investigation and not yet approved.

What other types of research exist?

Promising alternatives to probiotics for altering intestinal microbiota composition in Type 1 Diabetes patients include prebiotics, synbiotics, and fecal microbiota transplantation (FMT). These approaches aim to promote beneficial gut bacteria and modulate the immune system, potentially improving disease outcomes.

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Probiotic

Probiotics for Type 1 Diabetes

Phase 2

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)

Treatment naïve of any immunomodulatory agent

Must not have

Female participants of child-bearing age with reproductive potential must not be knowingly pregnant

Diabetes other than T1D

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years (duration of study)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Probiotics like Visbiome are generally considered safe but may cause digestive side effects such as gas, bloating, or discomfort. These effects usually resolve as the body adjusts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for diabetes-related autoantibodies.

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I have not received any immune system modifying treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and can have children.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years (duration of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years (duration of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years (duration of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis

Secondary study objectives

C-peptide decline

Feces

Cytokine Levels (a measure of inflammation) as measured by plasma analysis

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Group II: Placebo GroupPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes (T1D) include insulin therapy, immunotherapy, and probiotics. Insulin therapy replaces the insulin that the pancreas no longer produces, essential for regulating blood glucose levels. Immunotherapy aims to modulate the immune system to prevent it from attacking pancreatic beta cells. Probiotics are being studied for their potential to alter the intestinal microbiota composition, reducing dysbiosis and potentially influencing the inflammatory state that contributes to T1D progression. These treatments are crucial for T1D patients as they address both immediate symptom management and underlying disease mechanisms.

The Gut Microbiome of Adults With Type 1 Diabetes and Its Association With the Host Glycemic Control.Effect of Taro Starch, Beet Juice, Probiotic, and/or Psicose on Gut Microbiota in a Type 2 Diabetic Rat Model: A Pilot Study.The gut microbiota in type 1 diabetes: friend or foe?