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Lactobacillus Johnsonii in Children and Adolescents With T1D

NCT03961854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this 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

  • Type 1 Diabetes (T1D)

Interventions

DRUG

L. johnsonii Probiotic

Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.

DRUG

Placebo Capsule

Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Michael Haller · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2026-01-23
Completion
2026-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961854 on ClinicalTrials.gov