The Role of Gut and Skin Microbiota in Alopecia Areata

N/ANot Yet RecruitingNCT07705217

Polyclinic GrandMed30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alopecia Areata Fecal Microbiota Transplantation (FMT)T Cell Subsets Microbiome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes in hair growth- Severity of Alopecia Tool

The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in SALT (Severity of Alopecia Tool) score as a standardized measurement used to quantify scalp hair loss in patients with alopecia areata. The scale ranges from 0 (no hair loss) to 100 (complete scalp hair loss). A clinically meaningful reduction in SALT score (≥50% improvement from baseline) will be considered a strong indicator of therapeutic efficacy.