Alopecia AreataRGSM-AA-ICSNCT07705217
The Role of Gut and Skin Microbiota in Alopecia Areata
A study testing Fecal Microbial Transplant Enema in people with Alopecia Areata and Fecal Microbiota Transplantation (FMT), run by Polyclinic GrandMed at 1 site in Croatia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata, Fecal Microbiota Transplantation (FMT), T Cell Subsets
- What is being tested?
- Fecal Microbial Transplant Enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
Polyclinic GrandMed
Opatija
Tea Rosovic, Dermatovenerology specialist, +00385913737237, tearosovic@gmail.com
Tea Rosovic, Dermatovenerology specialist
About this study
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.
- Being tested
- Fecal Microbial Transplant Enema, Placebo
- Keywords
- alopecia areata, Fecal microbiota transplantation, FMT
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial Transplant EnemaOther
Also called FMT
Patients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy
PlaceboOther
Patients will recieve three capsules with inert material or saline via colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Experimental | Interventional group Receives: Other: Fecal Microbial Transplant Enema |
| Placebo group | Placebo comparator | This group will recieve placebo capsules or saline via colonoscopy Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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+)
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyclinic GrandMed
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tea Rosovic, Polyclinic GrandMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705217
- Sponsor's protocol ID
- TD25725
- Acronym
- RGSM-AA-ICS
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut and Skin Microbiota in Alopecia Areata
- ClinicalTrials.gov ID
- NCT07705217
- Acronym / sponsor ID
- RGSM-AA-ICS / TD25725
- Keywords
- alopecia areata, Fecal microbiota transplantation, FMT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Polyclinic GrandMedUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT group | Experimental | Other: Fecal Microbial Transplant EnemaInterventional group |
| Placebo group | Placebo comparator | Other: PlaceboThis group will recieve placebo capsules or saline via colonoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial Transplant EnemaAlso: FMTPatients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy | Other | FMT group |
| PlaceboPatients will recieve three capsules with inert material or saline via colonoscopy | Other | Placebo group |
Primary outcome
Changes in hair growth- Severity of Alopecia Tool
Time frame: From enrollment to the end of treatment at 48 weeks
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.
Changes in hair growth- Alopecia Areata Investigator Global Assessment
Time frame: From enrollment to the end of treatment at 48 weeks
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.
Changes in hair growth- The Alopecia Areata Scale
Time frame: From enrollment to the end of treatment at 48 weeks
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.
Fecal microbiota transplantation modulation of the gut and skin microbiota
Time frame: From enrollment to the end of treatment at 48 weeks
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.
Change in T cell subsets from Baseline to 48 weeks
Time frame: From enrollment to the end of treatment at 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+)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial Transplant Enema in people with Alopecia Areata and Fecal Microbiota Transplantation (FMT), run by Polyclinic GrandMed at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tea Rosovic, Dermatovenerology specialist (+00385913737237, tearosovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hair growth- Severity of Alopecia Tool (time frame: From enrollment to the end of treatment at 48 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.