The Role of Gut and Skin Microbiota in Alopecia Areata (RGSM-AA-ICS)

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 Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata; Microbiome; Fecal Microbiota Transplantation (FMT); T Cell Subsets
• Intervention / Treatment: Other: Fecal Microbial Transplant Enema; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tea Rosovic, Dermatovenerology specialist; Phone Number: +00385913737237; Email: tearosovic@gmail.com

Study Locations

• Croatia
  • Opatija, Croatia
    • Polyclinic GrandMed
    • Contact: Tea Rosovic, Dermatovenerology specialist; Phone Number: +00385913737237; Email: tearosovic@gmail.com
    • Principal Investigator: Tea Rosovic, Dermatovenerology specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT group; Interventional group	Other: Fecal Microbial Transplant Enema; Patients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy; Other Names: FMT
Placebo Comparator: Placebo group; This group will recieve placebo capsules or saline via colonoscopy	Other: Placebo; Patients will recieve three capsules with inert material or saline via colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Polyclinic GrandMed

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: FMT; Fecal microbiota transplantation; alopecia areata
• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: TD25725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No