Could a gut bacteria transplant restore hair in alopecia areata?
NCT ID NCT07705217
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Polyclinic GrandMed
Opatija, Croatia
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