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Not yet recruiting NCT07705217

The Role of Gut and Skin Microbiota in Alopecia Areata

No phase Interventional Alopecia Areata Fecal Microbiota Transplantation (FMT) T Cell Subsets Microbiome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal Microbial Transplant Enema, Placebo.
Who it may be relevant to
Registry conditions: Alopecia Areata, Fecal Microbiota Transplantation (FMT), T Cell Subsets, Microbiome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

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

Primary outcome measures

  • Changes in hair growth- Severity of Alopecia Tool [Time frame: From enrollment to the end of treatment at 48 weeks]
  • Changes in hair growth- Alopecia Areata Investigator Global Assessment [Time frame: From enrollment to the end of treatment at 48 weeks]
  • Changes in hair growth- The Alopecia Areata Scale [Time frame: From enrollment to the end of treatment at 48 weeks]
  • Fecal microbiota transplantation modulation of the gut and skin microbiota [Time frame: From enrollment to the end of treatment at 48 weeks]
  • Change in T cell subsets from Baseline to 48 weeks [Time frame: From enrollment to the end of treatment at 48 weeks]

Eligibility criteria

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).
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Croatia · 1 center
  • Polyclinic GrandMed — Opatija

Identifiers

NCT: NCT07705217 · TD25725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗