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Could a probiotic help kids with type 1 diabetes? new study explores

NCT ID NCT03961854

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 probiotic called Lactobacillus johnsonii N6.2 is safe and affects the immune system in 30 children and teens with type 1 diabetes. The goal was to see if the probiotic could help preserve the body's ability to produce insulin by improving gut health. Participants took the probiotic for 24 weeks and were monitored for side effects and changes in blood and stool samples.

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

30 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 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

8 to 18 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 complete blood count (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 * are willing to provide stool samples throughout the study * are willing to provide blood samples throughout the study * are willing to take three stimulated C-peptide tests * are able to access a computer with Internet throughout the study Exclusion Criteria: * being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's disease, ulcerative colitis, etc.) * being treated for chronic kidney disease * have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, organ transplant, 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.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes (T1D)

Contacts and locations

Locations

  • UF Clinical Research Center

    Gainesville, Florida, 32610, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.