drugset / Trial / NCT06058520

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

NCT06058520

Phase 0 Recruiting 16 enrolled University of Minnesota
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2023-10-01
Primary completion
2026-09-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Other / unclassified Oral