NCT03961347CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 22 May 2019
- Start date
- 1 Feb 2020
- Primary completion date
- 18 Mar 2026
- Lead sponsor
- University of Florida
- Diseases
- Type 1 diabetes
- NCT number
- NCT03961347
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 46
- From 1 Feb 2020 to the primary completion date, 18 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently taking medications for constipation and/or diarrhea.
- Have taken antibiotics within the past 2 weeks prior to randomization.
- Are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start.
Other illness
- Have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.).
- Have chronic disease kidney disease.
- Have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, transplant patient, Lupus, DiGeorge syndrome, selective deficiency of Immunoglobulin A (IgA), Bruton's disease etc.).
- Have an underlying structural heart disease.
- Have a known allergy to milk or milk protein.
Other
- Currently live with an immunocompromised person.
- Are a current smoker.
- Are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months.
Who the study is looking for
- Have confirmed T1D by physician diagnosis
- Have normal values at screening for CBC and complete metabolic profiles (with the exception of fasting glucose and HbA1c).
- Are able to swallow a capsule.
- Are willing to complete weekly online questionnaires.\*
- Are willing to consume a probiotic or placebo capsule daily for 24 weeks.
- Are willing to provide stool samples throughout the study.
- Are willing to provide blood samples throughout the study.
- Are willing to take three 2-hour Mixed-Meal Tolerance Tests (MMTTs).
- Are able to access a computer with Internet throughout the study.\*
- Note: Going into the study, we want the participants to have daily internet access. However, if this changes once they are in the study, we will provide paper copies of the questionnaires.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UF Clinical Research Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.