The Role of Gut and Skin Microbiota in Alopecia Areata (RGSM-AA-ICS)
10 juli 2026 bijgewerkt door: Tea Rosovic, Polyclinic GrandMed
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Tea Rosovic, Dermatovenerology specialist
- Telefoonnummer: +00385913737237
- E-mail: tearosovic@gmail.com
Studie Locaties
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Opatija, Kroatië
- Polyclinic GrandMed
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Contact:
- Tea Rosovic, Dermatovenerology specialist
- Telefoonnummer: +00385913737237
- E-mail: tearosovic@gmail.com
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Hoofdonderzoeker:
- Tea Rosovic, Dermatovenerology specialist
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: FMT group
Interventional group
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Patients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy
Andere namen:
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Placebo-vergelijker: Placebo group
This group will recieve placebo capsules or saline via colonoscopy
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Patients will recieve three capsules with inert material or saline via colonoscopy
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in hair growth- Severity of Alopecia Tool
Tijdsspanne: From enrollment to the end of treatment at 48 weeks
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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.
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From enrollment to the end of treatment at 48 weeks
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Changes in hair growth- Alopecia Areata Investigator Global Assessment
Tijdsspanne: From enrollment to the end of treatment at 48 weeks
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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.
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From enrollment to the end of treatment at 48 weeks
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Changes in hair growth- The Alopecia Areata Scale
Tijdsspanne: From enrollment to the end of treatment at 48 weeks
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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.
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From enrollment to the end of treatment at 48 weeks
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Fecal microbiota transplantation modulation of the gut and skin microbiota
Tijdsspanne: From enrollment to the end of treatment at 48 weeks
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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.
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From enrollment to the end of treatment at 48 weeks
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Change in T cell subsets from Baseline to 48 weeks
Tijdsspanne: From enrollment to the end of treatment at 48 weeks
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Before and after Fecal microbiota transplantation patient will be taken 60-80 ml of peripheral blood for:
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From enrollment to the end of treatment at 48 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 februari 2027
Studie voltooiing (Geschat)
1 oktober 2027
Studieregistratiedata
Eerst ingediend
26 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2026
Eerst geplaatst (Werkelijk)
15 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TD25725
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
IPD used in the results publication
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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