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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.
patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.
University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGEngraftment
Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.
Time frame: Week 8
Hair regrowth
Percent hair regrowth from baseline determined by SALT measurements following 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment.
Time frame: 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment
efficacy measure 2
Timing of relapse in responders followed for 6 months post therapy.
Time frame: 6 months post therapy
SALT Score
Proportion of patients in the treatment versus placebo group achieving SALT score of \<50% at week 24
Time frame: Week 24
safety outcome 2
Proportion of participants with a SAE through day 30 (±3 days) after MTT.
Time frame: day 30
safety outcome 3
Proportion of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through day 30 (±3 days) after MTT.
Time frame: day 30
safety outcome 1
Proportion of participants with an AE through day 30 (±3 days) after MTT.
Time frame: day 30
Week 4 AEs
Proportion of participants with an AE through week 4 (±5 days) after MTT.
Time frame: Week 4
Week 4 SAEs
Proportion of participants with an SAE through week 4 (±5 days) after MTT.
Time frame: Week 4
Month 6 SAEs
Proportion of participants with a SAE at month 6 (±14 days) after randomization.
Time frame: Month 6
Month 12 SAEs
Proportion of participants with a SAE at month 12 (±14 days) after randomization.
Time frame: Month 12
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