๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-14

Probiotics in Newly Diagnosed T1D (NCT04141761)

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ“‹ Clinical Research Protocol Sponsor: Medical College of Wisconsin

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Medical College of Wisconsin โ€” Milwaukee, Wisconsin

Age range: 5 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Type 1 Diabetes clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—