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Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

StatusRecruiting
PhaseEarly Phase 1
Started2023-12-27
View on ClinicalTrials.gov ↗
HS is relatively common in the United States with a prevalence of 0.1-1.0%. 1 HS has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (AD). HS also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. Unfortunately, few treatment options are effective. There are currently three FDA-approved treatments for HS, including adalimumab, secukinumab, and bimekizumab, each with only 40- 60% respond to treatment and over 50% lose response within one year . The overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(MTT) alters the gut microbiome in patients with Hidradenitis Suppurativa (HS), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.

Amendment history 2 changes detected by DataLookout

2026-09-04
notable
Primary completion pushed: 2026-09-01 → 2026-12-30
2026-09-04
minor
Completion pushed: 2026-09-01 → 2026-12-30
Trial Details
NCT Number NCT06058520
Lead Sponsor University of Minnesota
Conditions Hidradenitis Suppurativa
Enrollment 16 participants
Start Date 2023-12-27
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03