Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06058520

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Led by University of Minnesota · Updated on 2026-02-17

16

Participants Needed

1

Research Sites

152 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent
  • English speaking
  • Age 18 years or older
  • Diagnosis of hidradenitis suppurativa by a dermatologist
  • Women who are not post-menopausal or surgically sterile must use highly effective birth control or remain abstinent
  • Able to comply with study measures as determined by the investigator
  • Stable doses of all medications for 30 days prior to baseline
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Refusal or inability to provide informed consent
  • Planning to move within 6 months from start of study
  • Allergy to neomycin or vancomycin
  • Anaphylactic food allergies
  • Pregnancy, breastfeeding, or planning pregnancy during study (negative pregnancy test required 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
  • Major bowel surgery within 4 weeks prior to baseline or planned during study
  • Active skin disease other than HS that could interfere with assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

T

Thomas Pritchard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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