CompletedPhase 2

Lactobacillus Johnsonii Supplementation in Adults With T1D

United States46 participantsStarted 2020-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Currently live with an immunocompromised person. * Are currently taking medications for constipation and/or diarrhea. * Have taken antibiotics within the past 2 wee…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)

Timeframe: 52 weeks

Tolerance will be evaluated according to their responses on weekly questionnaires

Timeframe: 52 weeks

Adverse Event and/or Serious Adverse Event

Timeframe: 24 weeks

Trial details

NCT IDNCT03961347

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Type 1 Diabetes (T1D) trials