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COMPLETED
NCT03961854
PHASE2

Lactobacillus Johnsonii in Children and Adolescents With T1D

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2019-10-10

Completion Date

2026-01-23

Last Updated

2026-05-06

Healthy Volunteers

No

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.

Locations (1)

UF Clinical Research Center

Gainesville, Florida, United States