Evaluation of Microbiota Transplant Therapy for Alopecia Areata

This study is looking into a treatment for Alopecia Areata (AA), Alopecia Totalis, and Alopecia Universalis, which are conditions causing hair loss. It's testing whether a treatment called Microbiota Transplant Therapy (MTT) capsules, along with antibiotics (Vancomycin and Neomycin), can help. You would take two capsules daily for 14 days. Another group will receive placebo capsules (inactive capsules) for the same duration. The study aims to see if the treatment helps the new microbiota "engraft" or take hold, which will be checked at Week 8. To join, you need to be between 18 and 75 years old with moderate to severe AA (SALT score over 30%) and have had hair loss for at least 3 months with no current regrowth. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 40 participants. It compares two groups: one receiving Vancomycin, Neomycin, and MTT capsules, and another receiving placebo capsules.
What's involved
Participants will take two capsules daily for 14 days. After this, you will be clinically followed for a period of 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be clinically followed for 24 weeks after the 14-day treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06747611

Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

Recruiting
PHASE2Ages 18–75InterventionalTreatment
University of Minnesota
~40 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Vancomycin, Neomycin and MTT capsulesPlacebo capsules

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Engraftment
Measured over Week 8
Alopecia Areata
Alopecia Totalis
Alopecia Universalis
1 sites across 1 states
Minnesota1
  • Maria K Hordinsky, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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
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..
  • EngraftmentWeek 8

    Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.