Microbiota transplant to treat hair loss from alopecia areata

Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

This will try a short course of antibiotics followed by an oral microbiota transplant to see if adults with moderate-to-severe alopecia areata can regrow hair.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT06747611 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives participants a brief antibiotic regimen (vancomycin and neomycin) followed by oral microbiota transplant (MTT) capsules or placebo to test effects on hair regrowth. Eligible adults have moderate-to-severe disease (SALT >30%) including patchy alopecia areata, totalis, or universalis, and must have no active regrowth at baseline. Participants who are on JAK inhibitors must stop them one month before enrollment and for the study duration. The trial is conducted at the University of Minnesota and compares outcomes between the MTT and placebo groups over the study period.

Who should consider this trial

Good fit: Adults aged 18–75 with moderate-to-severe alopecia areata (SALT >30%), including totalis or universalis, without active baseline regrowth and willing to follow contraception and medication-hold requirements are ideal candidates.

Not a fit: People with active gastrointestinal disease, recent conflicting treatments, ongoing hair regrowth, or those unable to stop JAK inhibitors or meet contraception requirements may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, this approach could offer a new, non-systemic option to help people with moderate-to-severe alopecia areata regrow hair.

How similar studies have performed: Microbiota transplant for alopecia areata is largely novel with limited prior clinical evidence, though microbiome research offers a rationale for testing this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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..

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Maria K Hordinsky, MD — University of Minnesota
• Study coordinator: John Meisenheimer

Conditions Alopecia Areata; Alopecia Totalis; Alopecia Universalis