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NCT04335656 · ClinicalTrials.gov registry record · Phase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04335656: Active Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin.
NCT04335656 is a Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 60 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04335656, a Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Medical College of Wisconsin.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
Primary Outcome
Investigators will examine the effect of probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription and analyzed using a composite inflammatory index score. The investigators hypothesize that the subjects receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Lactiplantibacillus plantarum
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04335656 still lists
NCT04335656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04335656 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04335656 about?
NCT04335656 is a clinical study titled "Reducing Innate Inflammation in New Onset Type 1 Diabetes". This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the inte...
What is the current status of trial NCT04335656?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-04-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04335656 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT04335656?
The interventions under investigation include: Placebo (OTHER), Lactiplantibacillus plantarum (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04335656?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04335656 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04335656's enrollment target sits among peer trials
60 73rd of 198 higher than 117 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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