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Probiotics in Newly Diagnosed T1D

Primary Purpose

Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Visbiome
Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Newly diagnosed, Recent onset, Visbiome, Probiotic

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

C-peptide decline
Investigators will examine the effect of multistrain probiotic supplementation on the post-onset rate of C-peptide decline (a measure of beta cell health)
Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
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.
Cytokine Levels (a measure of inflammation) as measured by plasma analysis
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.
Changes to intestinal bacteria as measured by stool analysis
Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota
System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
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.

Full Information

First Posted
October 23, 2019
Last Updated
October 18, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04141761
Brief Title
Probiotics in Newly Diagnosed T1D
Official Title
Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus
Keywords
Newly diagnosed, Recent onset, Visbiome, Probiotic

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, placebo-controlled, 2:1 randomly assigned
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Visbiome
Intervention Description
This group will receive Visbiome probiotic in powder form.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
This group will receive a placebo in powder form.
Primary Outcome Measure Information:
Title
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
Description
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.
Time Frame
3 years (duration of study)
Secondary Outcome Measure Information:
Title
C-peptide decline
Description
Investigators will examine the effect of multistrain probiotic supplementation on the post-onset rate of C-peptide decline (a measure of beta cell health)
Time Frame
3 years (duration of study)
Title
Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
Description
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.
Time Frame
3 years (duration of study)
Title
Cytokine Levels (a measure of inflammation) as measured by plasma analysis
Description
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.
Time Frame
3 years (duration of study)
Title
Changes to intestinal bacteria as measured by stool analysis
Description
Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota
Time Frame
3 years (duration of study)
Title
System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
Description
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.
Time Frame
3 years (duration of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics in Newly Diagnosed T1D

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