Probiotics in Newly Diagnosed T1D

October 14, 2025 updated by: Susanne Cabrera, Medical College of Wisconsin

Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must meet all of the following criteria:

    1. Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
    2. Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
    3. Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
    4. Treatment naïve of any immunomodulatory agent

Exclusion Criteria:

  • Patients must NOT meet any of the following criteria:

    1. Probiotic use within 1 month of screening visit
    2. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
    3. Diabetes other than T1D
    4. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
    5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Other: Placebo
This group will receive a placebo in powder form.
Experimental: Treatment Group
Dietary supplement: Visbiome
This group will receive Visbiome probiotic in powder form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
Time Frame: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription analysis. The investigators hypothesize that the participants receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
3 years (duration of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-peptide decline
Time Frame: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation on the post-onset rate of C-peptide decline (a measure of beta cell health)
3 years (duration of study)
Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
Time Frame: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation on changes to the plasma-induced transcriptional assay to assess for probiotic-specific immune effects. Plasma-induced transcriptional analyses will be compared before and after treatment with probiotic/placebo. The investigators hypothesize that the participants receiving the probiotic will see reduced inflammation (as measured by transcriptional analysis) while those that received the placebo will see no change or increased inflammation.
3 years (duration of study)
Cytokine Levels (a measure of inflammation) as measured by plasma analysis
Time Frame: 3 years (duration of study)
Cytokine levels before and after treatment will be measured by plasma analysis. It is hypothesized that the levels of cytokines in the blood will be lower after treatment for the participants receiving the probiotic but not for those receiving the placebo.
3 years (duration of study)
Changes to intestinal bacteria as measured by stool analysis
Time Frame: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota
3 years (duration of study)
System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
Time Frame: 3 years (duration of study)
Gut leakiness will be measured by examining the levels of microbial antigens in the plasma before and after treatment and correlating these antigen levels with the changes in the composition of the gut bacteria. It is hypothesized that changes in antigen levels and gut bacteria will only be seen in the participants receiving the probiotic. It is further hypothesized that those with the greatest reduction in antigens will have the most significant changes in gut bacteria composition.
3 years (duration of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

March 30, 2023

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1343363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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