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NCT03961854 · ClinicalTrials.gov registry record · Phase 2
Lactobacillus Johnsonii in Children and Adolescents With T1D
A Phase 2 study of Type 1 Diabetes (T1D), sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03961854: Completed Phase 2 study of Type 1 Diabetes (T1D), sponsored by University of Florida.
NCT03961854 is a Phase 2 study of Type 1 Diabetes (T1D) that has completed, run by University of Florida. The registered enrollment target is 30 participants, below the 179-participant average among 17 other Type 1 Diabetes (T1D) trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03961854, a Phase 2 study of Type 1 Diabetes (T1D), has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.
Primary Outcome
CBC and CMP will be evaluated at four different time points during study: 1st measure will be at screening visit and before starting intervention (visit 1/week -4, baseline period), 2nd measure will be after 12 weeks after starting intervention (visit 2/ week 12), 3rd measure will be after the 24 weeks of intervention (visit 3/ week 24) and the 4th measure will be 24 weeks later, end of washout period (visit 4/week 48). Values should be within the normal values except for glucose.
Conditions Studied
Interventions
- DRUG L. johnsonii Probiotic
- DRUG Placebo Capsule
Study Locations (1)
Florida
- UF Clinical Research Center - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2026-01-23 |
| Phase | Phase 2 |
What the finished NCT03961854 record still lists
NCT03961854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 179-participant average among 17 other Type 1 Diabetes (T1D) trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Type 1 Diabetes (T1D) appearing as the primary indexed condition, and to 2 interventions - of which L. johnsonii Probiotic is the first listed.
NCT03961854 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03961854 about?
NCT03961854 is a clinical study titled "Lactobacillus Johnsonii in Children and Adolescents With T1D". While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show syst...
What is the current status of trial NCT03961854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-10-10. Estimated completion is 2026-01-23.
What conditions does trial NCT03961854 study?
This clinical trial studies the following conditions: Type 1 Diabetes (T1D).
What interventions are being tested in trial NCT03961854?
The interventions under investigation include: L. johnsonii Probiotic (DRUG), Placebo Capsule (DRUG).
Who is sponsoring clinical trial NCT03961854?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03961854 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes (T1D)
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 NCT03961854's enrollment target sits among peer trials
30 14th of 17 higher than 4 of 17 other Type 1 Diabetes (T1D) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes (T1D) 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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