Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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 facts

Study ID

NCT06058520

Run by

University of Minnesota

People needed

16

Starts

2023-10-01

Expected to finish

2026-09-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Non-English speaking
• Refusal or inability to provide informed consent
• Planning on moving within 6 months from start of study
• Allergy to neomycin or vancomycin
• Anaphylactic food allergies
• 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
• History of inflammatory bowel disease
• 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
• No active skin disease other than HS that could interfere with assessments

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.