The Role of Gut and Skin Microbiota in Alopecia Areata

NCT07705217 | Not Yet Recruiting

• 1 other identifier: TD25725
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

alopecia areata; Fecal microbiota transplantation; FMT

Outcome Measures

Primary Outcomes (5)

• 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.

  From enrollment to the end of treatment at 48 weeks

• Changes in hair growth- Alopecia Areata Investigator Global Assessment

  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 Alopecia Areata Investigator Global Assessment (AA-IGA) to measure five clinically meaningful gradations of alopecia areata scalp-hair loss that reflects patients' and clinicians' perspectives and expectations of treatment success in alopecia areata treatment studies. The AA-IGA score is based on the patient's SALT score. The scale is numbered from 0, which corresponds to 0% of hair loss (ie, SALT 0), indicating no hair loss, to 4, which corresponds to 95-100% of hair loss (ie, SALT 95-100), indicating very severe hair loss.

  From enrollment to the end of treatment at 48 weeks

• Changes in hair growth- The Alopecia Areata Scale

  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 The Alopecia Areata Scale (AASc) in wich primary criterion is Severity of scalp hair loss: mild 20% or less, moderate 21-49%, severe 50-100% scalp hair loss. Secondary criteria: is any is present, increase severity rating by one level: noticeable involvement of eyebrows or eyelashes; inadequate response after at least 6 months of treatment; negative impact on psychosocial functioning resulting from AA; diffuse (multifocal) positive hait pull test consistent with pidly progressive alopecia areata.

  From enrollment to the end of treatment at 48 weeks

• Fecal microbiota transplantation modulation of the gut and skin microbiota

  The primary objective of this proposal is to test the hypothesis that fecal microbiota transplantation (FMT) induces beneficial modulation of the gut and skin microbiota, leading to immunoregulatory effects in patients with alopecia areata (AA). Characterize baseline skin, and colonic mucosal microbiota composition in patients with AA using 16S rRNA sequencing of skin and colon musosa biopsy specimens and assess changes following FMT.

  From enrollment to the end of treatment at 48 weeks

• Change in T cell subsets from Baseline to 48 weeks

  Before and after Fecal microbiota transplantation patient will be taken 60-80 ml of peripheral blood for: * CBC, CRP * Flow cytometry analyses: Tumor necrosis factor alfa (TNFɑ), IL-10, IL-18, IFN-γ, IL-15, IL-2 and trichohyalin; CD4+ Th1 lymphocytes, CD8+ cytotoxic T cells, IFN-γ-producing lymphocytes, CXCR3+ T cells, NK cells, ILC1-like innate lymphoid cells, activated T cells expressing CD69 and HLA-DR, and regulatory T cells (CD4+CD25+FOXP3+)

  From enrollment to the end of treatment at 48 weeks

Study Arms (2)

FMT group

EXPERIMENTAL

Interventional group

Other: Fecal Microbial Transplant Enema

Placebo group

PLACEBO COMPARATOR

This group will recieve placebo capsules or saline via colonoscopy

Other: Placebo

Interventions

Fecal Microbial Transplant Enema OTHER

Patients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy

Also known as: FMT

FMT group

Placebo OTHER

Patients will recieve three capsules with inert material or saline via colonoscopy

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Prior FMT treatment for any condition.
• Therapy with new antidepressants or had a change in antidepressant dose within previous 3 months
• Serious medical comorbidities(including neurological or phychiatric comorbidities)
• Elevated C-reactive protein concentration, abnormal baseline laboratory tests
• Severe(anaphylactic) food allergy
• 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.

Sponsors & Collaborators

• Polyclinic GrandMed: lead

Study Sites (1)

Polyclinic GrandMed

Opatija, Croatia

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Tea Rosovic, Dermatovenerology specialist

CONTACT

+00385913737237; tearosovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatovenerology specialist

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CR (1)