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RECRUITING
NCT06058520
EARLY_PHASE1

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2023-10-01

Completion Date

2026-09-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Fecal Microbiota - lyophilized

Patients receive 2 capsules daily for one week followed by one capsule daily for 2 weeks. MTT capsules are derived from a single donor per patient.

DRUG

Placebo drug

The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States