NCT04141761Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 23 Oct 2019
- Start date
- 1 Apr 2019
- Primary completion date
- 30 Mar 2023
- Lead sponsor
- Medical College of Wisconsin
- Diseases
- Type 1 diabetes
- NCT number
- NCT04141761
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 1 Apr 2019 to the primary completion date, 30 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patients must NOT meet any of the following criteria:
- Probiotic use within 1 month of screening visit
- Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
- Diabetes other than T1D
- Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Who the study is looking for
- Patients must meet all of the following criteria:
- Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
- Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
- Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
- Treatment naïve of any immunomodulatory agent
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.