Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

A vizsgálat adatai

Ki végzi

University of Minnesota

Azonosító

NCT06058520

A regiszteradat frissítve

2026. szeptember 3.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: Able and willing to provide informed consent; English speaking; Age >= 18years of age; Diagnosis of hidradenitis suppurativa by a dermatologist; Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g. absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g. oral contraception, transdermal patch, barrier, intrauterine device). Periodic abstinence and early withdraw are not acceptable methods; Able to comply to study measures in the opinion of the investigator; Stable doses of all medications for 30 days prior to baseline.

Kizáró feltételek: Extensive bowel resection (e.g., subtotal colectomy, substantial removal of small bowel); No major bowel surgery within 4 weeks prior to baseline or planned major surgery during the study period; Allergy to neomycin or vancomycin; Anaphylactic food allergies; History of inflammatory bowel disease; No active skin disease other than HS that could interfere with assessments; Non-English speaking; Refusal or inability to provide informed consent; Planning on moving within 6 months from start of study; Pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential); Use of any topical or oral antibiotics within 30 days of randomization; Use of any oral antibiotics within 90 days of randomization.

ClinicalTrials.gov NCT06058520