Trials / Active Not Recruiting
Active Not RecruitingNCT03961347
Lactobacillus Johnsonii Supplementation in Adults With T1D
Evaluation of Safety, Tolerability and Immunological Responses to Lactobacillus Johnsonii N6.2 Supplementation in Adults With Diabetes Type 1
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 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
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
- 2020-02-01
- Primary completion
- 2026-03-18
- Completion
- 2026-03-18
- First posted
- 2019-05-23
- Last updated
- 2026-03-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03961347. Inclusion in this directory is not an endorsement.