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Could a probiotic help tame type 1 diabetes? new study tests safety

NCT ID NCT03961347

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a daily probiotic capsule containing Lactobacillus johnsonii N6.2 is safe for adults with type 1 diabetes and whether it affects the immune system. 46 participants took either the probiotic or a placebo for 24 weeks. Researchers monitored blood counts, metabolic panels, and any side effects like stomach discomfort. The goal was to see if this probiotic could help restore gut balance and potentially preserve insulin-producing cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactobacillus johnsonii N6.2 probiotic
What this could lead to
If this probiotic is shown to be safe and to improve immune balance, it could point toward a new way to help manage type 1 diabetes by supporting gut health.
What could go wrong
This is a small, early-phase trial focused on safety and immune markers, not on controlling blood sugar or curing diabetes. The probiotic may have no meaningful effect on the disease itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Feb 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. * Are a current smoker. * Are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months. * Have a known allergy to milk or milk protein.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UF Clinical Research Center

    Gainesville, Florida, 32610, United States

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