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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years (duration of study)
Awards & highlights

Study Summary

This trial is testing whether probiotics can help improve the health of people 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.Check my eligibility
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.See study design
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
Select...
I have tested positive for diabetes-related autoantibodies.
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I have not received any immune system modifying treatments.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,540 Total Patients Enrolled

Media Library

Visbiome (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04141761 — Phase 2
Type 1 Diabetes Research Study Groups: Treatment Group, Placebo Group
Type 1 Diabetes Clinical Trial 2023: Visbiome Highlights & Side Effects. Trial Name: NCT04141761 — Phase 2
Visbiome (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141761 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being enrolled in this research project?

"The clinical trial mentioned is not currently looking for participants according to the latest update on clinicaltrials.gov. The study was created on April 1st, 2019 but has not been updated since November 28th, 2021. There are 1312 other trials that patients can consider signing up for."

Answered by AI

Could I possibly enroll in this clinical trial?

"This study is seeking to enroll 60 children and adolescents between the ages of 5 and 17 who have type 1 diabetes mellitus."

Answered by AI

Does Visbiome carry any safety risks for human patients?

"While Phase 2 trials are not as reliable in terms of patient safety, Visbiome still received a score of 2."

Answered by AI

Does this research require all participants to be below a certain age?

"This particular study's age limit is 17 years old, with the minimum age being 5."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Probiotics in Newly Diagnosed T1D
Susanne Cabrera 2019. "Probiotics in Newly Diagnosed T1D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04141761.
~7 spots leftby Apr 2025
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