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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visbiome | Dietary Supplement | This group will receive Visbiome probiotic in powder form. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 years (duration of study) |
| Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses |
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Inclusion Criteria:
Patients must meet all of the following criteria:
Exclusion Criteria:
Patients must NOT meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single-blind, placebo-controlled, 2:1 randomly assigned
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| Placebo |
| Other |
This group will receive a placebo in powder form. |
|
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 years (duration of study) |
| 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. | 3 years (duration of study) |
| Changes to intestinal bacteria as measured by stool analysis | Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota | 3 years (duration of study) |
| 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. | 3 years (duration of study) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |