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Could a probiotic protect Insulin-Making cells in newly diagnosed type 1 diabetes?

NCT ID NCT04335656

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a probiotic called Lactiplantibacillus plantarum (Lp299v) can reduce inflammation and help preserve the body's ability to make insulin in people newly diagnosed with type 1 diabetes. The study includes 60 participants aged 3 to 45 who were diagnosed within the last 100 days. Half will take the probiotic daily for 6 months, and the other half will take a placebo, with researchers measuring changes in inflammation and insulin production.

What this could mean

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

Active substance
Lactiplantibacillus plantarum (Lp299v) probiotic
What this could lead to
If it works, this could point toward a way to help preserve the body's own insulin production in people newly diagnosed with type 1 diabetes.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The probiotic may not reduce inflammation or slow disease progression as hoped.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

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

3 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: 1. ≤ 100 days from T1D diagnosis based on ADA criteria 2. \> 21 days from T1D diagnosis or metabolically stable per study physician assessment 3. Males and females 3-45 years of age, inclusive, at time of screening visit 4. Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L 5. Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit 6. Females of child-bearing potential (defined as any female who has reached menarche (first menses), excluding those who have had a hysterectomy or are post-menopausal and must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit 7. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age Exclusion Criteria: 1. Probiotic supplement use within the past month 2. Antibiotic use within the past month 3. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia 4. Females who are pregnant or lactating 5. Chronic inflammatory or autoimmune disease with exception of stable thyroid disease 6. Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease (i.e., clinically obtained tissue transglutaminase IgA titers above reference range, being referred to gastroenterology for possible endoscopy, etc.) 7. Use of glucocorticoids or other immunosuppressive agents within 30 days of screening MMTT 8. Use of medications known to influence glucose tolerance 9. Dairy allergy 10. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

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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

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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