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NCT06747611 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
A Phase 2 study of Alopecia Areata and Alopecia Totalis, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06747611 is a Phase 2 study of Alopecia Areata and Alopecia Totalis that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 40 participants, below the 1,954-participant average among 26 other Alopecia Areata trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06747611, a Phase 2 study of Alopecia Areata and Alopecia Totalis, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 immu
Conditions Studied
Interventions
- DRUG Vancomycin, Neomycin and MTT capsules
- DRUG Placebo capsules
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-08-21 |
| Est. Completion | 2028-03-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06747611
The ClinicalTrials.gov registry entry for NCT06747611 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,954-participant average among 26 other Alopecia Areata trials with a reported enrollment target (98% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alopecia Areata appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin, Neomycin and MTT capsules is the first listed.
NCT06747611 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06747611 about?
NCT06747611 is a clinical study titled "Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata". 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 femal...
What is the current status of trial NCT06747611?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-08-21. Estimated completion is 2028-03-15.
What conditions does trial NCT06747611 study?
This clinical trial studies the following conditions: Alopecia Areata, Alopecia Totalis, Alopecia Universalis.
What interventions are being tested in trial NCT06747611?
The interventions under investigation include: Vancomycin, Neomycin and MTT capsules (DRUG), Placebo capsules (DRUG).
Who is sponsoring clinical trial NCT06747611?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06747611 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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