NCT03961854

Lactobacillus Johnsonii in Children and Adolescents With T1D

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-10
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2019-05-23
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study