Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 is only one currently FDA-approved treatment, adalimumab, but 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Irmina Wallander
wall0396@umn.edu
612-624-5721
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 16
Treatments
Experimental: MMT group
patients with HS randomized to receive MTT
Placebo_comparator: Placebo group
patients with HS randomized to receive placebo treatment
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov