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Probiotics in Newly Diagnosed T1D

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ClinicalTrials.gov Identifier: NCT04141761
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Susanne Cabrera, Medical College of Wisconsin

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
Type 1 Diabetes Type1diabetes Type 1 Diabetes Mellitus Dietary Supplement: Visbiome Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-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 : April 1, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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. 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.

  4. 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

  5. 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141761


Contacts
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Contact: Susanne Cabrera, MD 414-955-4903 t1dinfo@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Susanne Cabrera, MD    414-955-4903    t1dinfo@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
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Responsible Party: Susanne Cabrera, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04141761    
Other Study ID Numbers: 1343363
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanne Cabrera, Medical College of Wisconsin:
Newly diagnosed
Recent onset
Visbiome
Probiotic
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases