Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

NCT06747611 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DERM-2022-30819
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia Areata; Alopecia Totalis; Alopecia Universalis

Outcome Measures

Primary Outcomes (1)

• Engraftment

  Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.

  Week 8

Secondary Outcomes (10)

• Hair regrowth

  8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment

• efficacy measure 2

  6 months post therapy

• SALT Score

  Week 24

• safety outcome 2

  day 30

• safety outcome 3

  day 30

Study Arms (2)

Alopecia Areata study group

EXPERIMENTAL

randomized to receive antibiotics and MTT oral capsule

Drug: Vancomycin, Neomycin and MTT capsules

Alopecia Areata control group

PLACEBO COMPARATOR

randomized to receive placebo antibiotics and placebo MTT oral capsule

Drug: Placebo capsules

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.

Alopecia Areata study group

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.

Alopecia Areata control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Columbia University: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

Vancomycin; Neomycin; monooxyethylene trimethylolpropane tristearate

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides

Study Officials

• Maria K Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Meisenheimer

CONTACT

612-625-2624; jmeisenh@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: August 21, 2025
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (1)