NCT04141761

Probiotics in Newly Diagnosed T1D

Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Type1diabetes
• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Visbiome	This group will receive Visbiome probiotic in powder form.
OTHER	Placebo	This group will receive a placebo in powder form.

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-03-30
• Completion: 2027-06-30
• First posted: 2019-10-28
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States