Probiotics in Newly Diagnosed T1D

NCT ID: NCT04141761

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Type 1 Diabetes; Type1diabetes; Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

Group Type: EXPERIMENTAL

Visbiome

Intervention Type: DIETARY_SUPPLEMENT

This group will receive Visbiome probiotic in powder form.

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

This group will receive a placebo in powder form.

Interventions

Visbiome

This group will receive Visbiome probiotic in powder form.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

This group will receive a placebo in powder form.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Susanne Cabrera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1343363

Identifier Type: -

Identifier Source: org_study_id