The Role of Gut and Skin Microbiota in Alopecia Areata (NCT07705217) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Role of Gut and Skin Microbiota in Alopecia Areata
Croatia30 participantsStarted 2026-10
Plain-language summary
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) works to treat alopecia areata in adults. It will also learn about the safety of FMT. The main questions it aims to answer are:
* Can FMT cause hair regrowth?
* Can FMT modulate immune response? Researchers will compare FMT to a placebo (a look-alike substance that contains no drug) to see if FMT works to treat alopecia areata.
Participants will:
* Take FMT or a placebo for three consecutive days
* Follow-up evaluations will be performed at weeks 12, 24, and 48, with repeat clinical scoring, photodocumentation, microbiome analyses, laboratory testing, and quality-of-life assessment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 18-65 diagnosed with Alopecia Areata (patchy or extensive) up to 10 years
. Willingness to adhere to study protocols, including FMT administration via capsules or colonoscopy.
. Ability to sign informed consent.
. SALT score≥ 20
Exclusion criteria
. History of gastrointestinal disorders (e.g., IBD, celiac disease).
. Recent use of antibiotics, probiotics, or prebiotics (within 2 months).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in hair growth- Severity of Alopecia Tool
Timeframe: From enrollment to the end of treatment at 48 weeks
2
Changes in hair growth- Alopecia Areata Investigator Global Assessment
Timeframe: From enrollment to the end of treatment at 48 weeks
3
Changes in hair growth- The Alopecia Areata Scale
Timeframe: From enrollment to the end of treatment at 48 weeks
4
Fecal microbiota transplantation modulation of the gut and skin microbiota
Timeframe: From enrollment to the end of treatment at 48 weeks
5
Change in T cell subsets from Baseline to 48 weeks
Timeframe: From enrollment to the end of treatment at 48 weeks