Microbiota transplant to treat hair loss from alopecia areata

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Maria K Hordinsky, MD — University of Minnesota
• Study coordinator: Thomas Pritchard
• Email: pritc204@umn.edu
• Phone: 612-626-0249

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for systemic treatments of alopecia areata

  This study is trying to see how well different systemic treatments work for people with moderate-to-severe alopecia areata, alopecia totalis, and alopecia universalis.

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• Which works better for patchy hair loss: steroid injections or microneedling with steroid cream?

  This trial tests whether injecting triamcinolone into the skin or using microneedling with topical triamcinolone helps people with alopecia areata regrow hair more effectively.

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• Red Ultraviolet Hair Imaging and Hair Growth in Alopecia Areata

  This observational study checks if red fluorescence seen with UV hair imaging relates to disease features and how well hair regrows after standard intralesional corticosteroid treatment in adults with limited plaque-type alopecia areata.

  Recruiting Istanbul Training and Research Hospital · Istanbul · NCT07803874

• VC005 tablets in teens with severe alopecia areata

  This Phase 1 study tests VC005 tablets in adolescents with severe alopecia areata to see how the drug behaves in the body, whether it is safe, and if there are signs of benefit.

  Recruiting Phase 1 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijing Municipality · NCT07762443

• VC005 tablets in severe alopecia areata

  This study tests whether VC005 tablets work better than a placebo for adults with severe alopecia areata.

  Recruiting Phase 2 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijing Municipality · NCT07749716

• Ritlecitinib for patchy hair loss in teens and adults with alopecia areata

  This study tests whether ritlecitinib can help people 12 and older with patchy alopecia areata who have had symptoms for 6 months to 10 years.

  Recruiting at 30 sites Phase 3 Pfizer · Encinitas, California and 37 other locations · NCT07733765

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.