Alopecia AreataPhase 2NCT06747611
Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
A Phase 2 study testing Vancomycin, Neomycin and MTT capsules in people with Alopecia Areata and Alopecia Totalis, run by University of Minnesota at 1 site in United States.
Trial summary
Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- Vancomycin, Neomycin and MTT capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 15 Mar 2028
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 75 years of age with moderate to severe alopecia areata (SALT score >30%).
- Patients with a diagnosis of patch type alopecia areata, totalis, or universalis..
- Duration of hair loss >=3 months..
- No evidence of active, ongoing regrowth present at baseline.
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening and immediately prior to MTT.
- Females of childbearing potential must agree to use an effective form of contraception from 14 days prior to study antibiotics through at least 30 days after MTT. Acceptable forms of contraception include oral or intramuscular contraceptives, intrauterine devices, surgical sterilization.
- Participants are not enrolled in another clinical study.
- If undergoing treatment with a JAK inhibitor, participant is willing to discontinue treatment for 1 month prior to enrollment and throughout the duration of the study.
Who cannot join
- Active gastrointestinal infection at time of enrollment.
- Having been administered antibiotics in the last 48 hours.
- Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to treatment..
- Requires continued antibiotic use
- Allergy to study antibiotics (vancomycin, neomycin).
- Known or suspected severe gastrointestinal dysmotility disorder, e.g., gastroparesis, pseudo-obstruction, scleroderma with gastrointestinal involvement
Show all 24Show fewer
- Ileus or small bowel obstruction.
- Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
- History of total colectomy.
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
- Unable or unwilling to comply with protocol requirements.
- Expected life expectancy \< 6 months.
- Previous MTT or microbiome-based products at any time excluding this study.
- History of severe anaphylactic or anaphylactoid food allergy.
- Solid organ transplant recipients 90 days post-transplant or on active treatment for rejection.
- A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
- History of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas.
- Patients in whom the diagnosis of alopecia areata is questionable.
- Patients in whom regrowth is present/evident at baseline in the areas to be treated.
- Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
- Patients unwilling or unable to discontinue treatments known to affect hair regrowth in alopecia areata.
- Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil, JAK inhibitors or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit..
- Patients determined by the investigator to have extreme diets..
- Pregnant and breastfeeding females..
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Thomas Pritchard, 612-626-0249, pritc204@umn.edu
About this study
Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. AA affects about 5.3 million people in the United States alone, including males and females across all ethnic groups, with a lifetime risk of 2.1%. Autoimmunity develops against the hair follicle, resulting in non-scarring hair loss that may begin as patches that can coalesce and progress to cover the entire scalp (alopecia totalis) or eventually the entire body (alopecia universalis). In AA, there is no permanent destruction of the hair follicle, and regrowth remains possible. Treatment options for AA include intralesional steroids, topical anthralin, allergic contact dermatitis with diphencyprone (DPCP), dinitrochlorobenzene (DNCB), or squaric acid dibutyl ester (SADBE), and recently janus kinase ( JAK) inhibitors. Despite the recent approval of JAKs for the treatment of extensive alopecia areata, some patients are treatment resistant, suffer relapses, or cannot take an oral immunosuppressive medication.
This study will attempt to elucidate the pre-treatment and post treatment skin and gut microbiome composition to determine whether specific bacterial species may correlate with disease or treatment response. To determine the effects of MTT on immune cell composition and activation systemically and locally in the skin, we will analyze major immune cell populations in peripheral blood samples and collect skin biopsies for histopathology and next generation sequencing analyses. Further, to determine if changes in immune cell populations affect the inflammatory response, we will profile inflammatory cytokines. To identify if changes in the gut microbiota influence the metabolic signature in AA, we will also perform untargeted metabolomics in stool gut microbiome samples and in plasma. Altogether, this comprehensive approach aims to identify the pathogenic immunological mechanisms associated with microbiome composition correlated to pre-treatment disease, post-treatment response, and any non-responders to treatment.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Being tested
- Vancomycin, Neomycin and MTT capsules, Placebo capsules
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin, Neomycin and MTT capsulesDrug
patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.
Placebo capsulesDrug
patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alopecia Areata study group | Experimental | randomized to receive antibiotics and MTT oral capsule Receives: Drug: Vancomycin, Neomycin and MTT capsules |
| Alopecia Areata control group | Placebo comparator | randomized to receive placebo antibiotics and placebo MTT oral capsule Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment
Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.
Measured: Week 8
Secondary outcomes (10)
Hair regrowth
Percent hair regrowth from baseline determined by SALT measurements following 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment.
Measured: 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment
efficacy measure 2
Timing of relapse in responders followed for 6 months post therapy.
Measured: 6 months post therapy
SALT Score
Proportion of patients in the treatment versus placebo group achieving SALT score of <50% at week 24
Measured: Week 24
safety outcome 2
Proportion of participants with a SAE through day 30 (±3 days) after MTT.
Measured: day 30
safety outcome 3
Proportion of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through day 30 (±3 days) after MTT.
Measured: day 30
safety outcome 1
Proportion of participants with an AE through day 30 (±3 days) after MTT.
Measured: day 30
Week 4 AEs
Proportion of participants with an AE through week 4 (±5 days) after MTT.
Measured: Week 4
Week 4 SAEs
Proportion of participants with an SAE through week 4 (±5 days) after MTT.
Measured: Week 4
Month 6 SAEs
Proportion of participants with a SAE at month 6 (±14 days) after randomization.
Measured: Month 6
Month 12 SAEs
Proportion of participants with a SAE at month 12 (±14 days) after randomization.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start21 Aug 2025
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Maria K Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747611
- Sponsor's protocol ID
- DERM-2022-30819
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
- ClinicalTrials.gov ID
- NCT06747611
- Acronym / sponsor ID
- DERM-2022-30819
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 24 Dec 2024 (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.
Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. AA affects about 5.3 million people in the United States alone, including males and females across all ethnic groups, with a lifetime risk of 2.1%. Autoimmunity develops against the hair follicle, resulting in non-scarring hair loss that may begin as patches that can coalesce and progress to cover the entire scalp (alopecia totalis) or eventually the entire body (alopecia universalis). In AA, there is no permanent destruction of the hair follicle, and regrowth remains possible. Treatment options for AA include intralesional steroids, topical anthralin, allergic contact dermatitis with diphencyprone (DPCP), dinitrochlorobenzene (DNCB), or squaric acid dibutyl ester (SADBE), and recently janus kinase ( JAK) inhibitors. Despite the recent approval of JAKs for the treatment of extensive alopecia areata, some patients are treatment resistant, suffer relapses, or cannot take an oral immunosuppressive medication.
This study will attempt to elucidate the pre-treatment and post treatment skin and gut microbiome composition to determine whether specific bacterial species may correlate with disease or treatment response. To determine the effects of MTT on immune cell composition and activation systemically and locally in the skin, we will analyze major immune cell populations in peripheral blood samples and collect skin biopsies for histopathology and next generation sequencing analyses. Further, to determine if changes in immune cell populations affect the inflammatory response, we will profile inflammatory cytokines. To identify if changes in the gut microbiota influence the metabolic signature in AA, we will also perform untargeted metabolomics in stool gut microbiome samples and in plasma. Altogether, this comprehensive approach aims to identify the pathogenic immunological mechanisms associated with microbiome composition correlated to pre-treatment disease, post-treatment response, and any non-responders to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alopecia Areata study group | Experimental | Drug: Vancomycin, Neomycin and MTT capsulesrandomized to receive antibiotics and MTT oral capsule |
| Alopecia Areata control group | Placebo comparator | Drug: Placebo capsulesrandomized to receive placebo antibiotics and placebo MTT oral capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 18 to 75 years of age with moderate to severe alopecia areata (SALT score >30%).
- Patients with a diagnosis of patch type alopecia areata, totalis, or universalis..
- Duration of hair loss >=3 months..
- No evidence of active, ongoing regrowth present at baseline.
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening and immediately prior to MTT.
Key exclusion criteria (24 listed)
- Active gastrointestinal infection at time of enrollment.
- Having been administered antibiotics in the last 48 hours.
- Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to treatment..
- Requires continued antibiotic use
- Allergy to study antibiotics (vancomycin, neomycin).
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 |
|---|---|---|
| Vancomycin, Neomycin and MTT capsulespatients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks. | Drug | Alopecia Areata study group |
| Placebo capsulespatients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks. | Drug | Alopecia Areata control group |
Primary outcome
Engraftment
Time frame: Week 8
Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.
10 secondary outcomes
Hair regrowth
Time frame: 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment
efficacy measure 2
Time frame: 6 months post therapy
SALT Score
Time frame: Week 24
safety outcome 2
Time frame: day 30
safety outcome 3
Time frame: day 30
safety outcome 1
Time frame: day 30
Week 4 AEs
Time frame: Week 4
Week 4 SAEs
Time frame: Week 4
Month 6 SAEs
Time frame: Month 6
Month 12 SAEs
Time frame: Month 12
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 26 Jun 2026.
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
Maria K Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin, Neomycin and MTT capsules in people with Alopecia Areata and Alopecia Totalis, run by University of Minnesota at 1 site in United States.
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 8 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 26 Jun 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thomas Pritchard (612-626-0249, pritc204@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment (time frame: Week 8). 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 26 Jun 2026.