Probiotics in Newly Diagnosed T1D

NCT04141761 | Active Not Recruiting Phase 2

• 1 other identifier: 1343363
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Newly diagnosed; Recent onset; Visbiome; Probiotic

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (5)

• C-peptide decline

  3 years (duration of study)

• Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses

  3 years (duration of study)

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

  3 years (duration of study)

• Changes to intestinal bacteria as measured by stool analysis

  3 years (duration of study)

• System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis

  3 years (duration of study)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Dietary Supplement: Visbiome

Placebo Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Visbiome DIETARY_SUPPLEMENT

This group will receive Visbiome probiotic in powder form.

Treatment Group

Placebo OTHER

This group will receive a placebo in powder form.

Placebo Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind, placebo-controlled, 2:1 randomly assigned

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: April 1, 2019
• Primary Completion: March 30, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)