The Role of Gut and Skin Microbiota in Alopecia Areata (RGSM-AA-ICS)
10 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tea Rosovic, Dermatovenerology specialist
- Número de teléfono: +00385913737237
- Correo electrónico: tearosovic@gmail.com
Ubicaciones de estudio
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Opatija, Croacia
- Polyclinic GrandMed
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Contacto:
- Tea Rosovic, Dermatovenerology specialist
- Número de teléfono: +00385913737237
- Correo electrónico: tearosovic@gmail.com
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Investigador principal:
- Tea Rosovic, Dermatovenerology specialist
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in hair growth- Severity of Alopecia Tool
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TD25725
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
IPD used in the results publication
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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