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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Fecal Microbial Transplant Enema
Other interventionPatients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy
Placebo
Other interventionPatients will recieve three capsules with inert material or saline via colonoscopy
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: FMT groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 48 weeks2
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.
Time frame
From enrollment to the end of treatment at 48 weeks3
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.
Time frame
From enrollment to the end of treatment at 48 weeks4
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.
Time frame
From enrollment to the end of treatment at 48 weeksSponsors and contacts
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Source ClinicalTrials.gov
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