Probiotics in Newly Diagnosed T1D

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04141761
Collaborator
(none)
60
1
2
69.1
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Visbiome
  • Other: Placebo
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind, placebo-controlled, 2:1 randomly assignedSingle-blind, placebo-controlled, 2:1 randomly assigned
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Dietary Supplement: Visbiome
This group will receive Visbiome probiotic in powder form.

Placebo Comparator: Placebo Group

Other: Placebo
This group will receive a placebo in powder form.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. C-peptide decline [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)

  2. Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses [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. Cytokine Levels (a measure of inflammation) as measured by plasma analysis [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.

  4. Changes to intestinal bacteria as measured by stool analysis [3 years (duration of study)]

    Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susanne Cabrera, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT04141761
Other Study ID Numbers:
  • 1343363
First Posted:
Oct 28, 2019
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Susanne Cabrera, Principal Investigator, Medical College of Wisconsin
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021