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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Type1diabetes Type 1 Diabetes Mellitus||Dietary Supplement: Visbiome Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-blind, placebo-controlled, 2:1 randomly assigned|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Experimental: Treatment Group||
Dietary Supplement: Visbiome
This group will receive Visbiome probiotic in powder form.
|Placebo Comparator: Placebo Group||
This group will receive a placebo in powder form.
- 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.
- 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)
- 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.
- 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.
- 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
- 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.
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
|Contact: Susanne Cabrera, MDemail@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Susanne Cabrera, MD 414-955-4903 firstname.lastname@example.org|