The Role of Gut and Skin Microbiota in Alopecia Areata
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPolyclinic GrandMed
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
History of gastrointestinal disorders (e.g., IBD, celiac disease).
Recent use of antibiotics, probiotics, or prebiotics (within 2 months).
Pregnant or breastfeeding women of childbearing potential who are unwilling or unable to use an acceptable method of birth control.
Individuals with immunocompromised or immunosuppressed states (e.g., HIV, cancer).
Trial design
Treatments tested in this trial
- Fecal Microbial Transplant Enema
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov