Clinical Trial

Probiotics in Newly Diagnosed T1D

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2019-10-24; most recent amendment 2025-10-14.
Status change: Recruiting → Active, Not Recruiting 2021-04-23
Trial Details
NCT Number NCT04141761
Lead Sponsor Medical College of Wisconsin
Conditions Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus
Enrollment 43 participants
Start Date 2019-04-01
Primary Completion 2023-03-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-16