Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT04141761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-16
First Post:
2019-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in Newly Diagnosed T1D
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: