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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 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.

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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.

Conditions Studied

Type 1 Diabetes (T1D)

Interventions

  • DRUG L. johnsonii Probiotic
  • DRUG Placebo Capsule

Study Locations (1)

Florida

  • UF Clinical Research Center - Gainesville

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-10-10
Est. Completion 2026-01-23
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT03961854

The ClinicalTrials.gov registry entry for NCT03961854 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 17 other Type 1 Diabetes (T1D) trials with a reported enrollment target (83% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.