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Status:

RECRUITING

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Lead Sponsor:

University of Minnesota

Conditions:

Hidradenitis Suppurativa

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT06058520

Start Date

October 1 2023

End Date

September 1 2026

Last Update

December 23 2025

Active Locations (1)

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1

University of Minnesota

Minneapolis, Minnesota, United States, 55414