RecruitingPhase 2

Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

United States40 participantsStarted 2025-08-21

Plain-language 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. 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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. * Majo…

What they're measuring

Engraftment

Timeframe: Week 8

Trial details

NCT IDNCT06747611

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-15

Contact for this trial

John Meisenheimer

612-625-2624 jmeisenh@umn.edu