Could a gut bacteria transplant restore hair in alopecia areata?

NCT ID NCT07705217

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 This study
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
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 Results may not be published yet.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
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Status unknown
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First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial investigates whether fecal microbiota transplantation (FMT) can treat alopecia areata, an autoimmune condition causing patchy hair loss. Researchers will give adults with alopecia areata either FMT or a placebo for three days and track hair regrowth, immune changes, and gut and skin bacteria over 48 weeks. The goal is to see if restoring healthy gut bacteria can calm the immune attack on hair follicles.

What this could mean

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

Active substance
fecal microbiota transplantation (FMT) via capsules or enema
What this could lead to
If it works, this could point toward a new treatment for alopecia areata by restoring healthy gut and skin bacteria to calm the immune system and trigger hair regrowth.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. FMT is still experimental for this condition, and its long-term safety and effectiveness are unknown.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

18 to 65 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. Adults aged 18-65 diagnosed with Alopecia Areata (patchy or extensive) up to 10 years 2. Willingness to adhere to study protocols, including FMT administration via capsules or colonoscopy. 3. Ability to sign informed consent. 4. SALT score≥ 20 Exclusion Criteria: 1. History of gastrointestinal disorders (e.g., IBD, celiac disease). 2. Recent use of antibiotics, probiotics, or prebiotics (within 2 months). 3. Pregnant or breastfeeding women of childbearing potential who are unwilling or unable to use an acceptable method of birth control. 4. Individuals with immunocompromised or immunosuppressed states (e.g., HIV, cancer). 5. Prior FMT treatment for any condition. 6. Therapy with new antidepressants or had a change in antidepressant dose within previous 3 months 7. Serious medical comorbidities(including neurological or phychiatric comorbidities) 8. Elevated C-reactive protein concentration, abnormal baseline laboratory tests 9. Severe(anaphylactic) food allergy 10. Concomitant treatments for AA: topical KS 1 week prior to randomization, topical JAK inhibitor, diphenylcyclopropenone, or other topical immunotherapies within 4 weeks prior to randomization;systemic corticosterids, immunosuppressant, intra-lesional or intra-articular corticosteroid injections, or oral JAK inhibitor within 8 weeks prior to randomization;monoclonal antibody \<5 half-lives prior to randomization; probenecid at the time of randomization. Bimatoprost ophtalmic solution was allowed if on stable dose for 8 weeks.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Polyclinic GrandMed

    Opatija, Croatia

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