Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06747611
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin, Neomycin and MTT capsules — DRUG
    patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.
  • Placebo capsules — DRUG
    patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
Sep 2025
Primary completion
Mar 15, 2028
Completion
Mar 15, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Alopecia Areata study group
    randomized to receive antibiotics and MTT oral capsule
  • Placebo Comparator: Alopecia Areata control group
    randomized to receive placebo antibiotics and placebo MTT oral capsule

Primary Outcome Measure

Engraftment [ Time Frame: Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
John Meisenheimer
[email protected]
612-626-9183

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By research site
University of Minnesota· Minneapolis, MN

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