Capsule microbiota transplant therapy for hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to explore the effects of oral microbiota transplant therapy on patients with hidradenitis suppurativa (HS), a chronic skin condition that significantly impacts quality of life. The study will investigate whether altering the gut microbiome can influence skin microbiota through metabolites absorbed from the gut. Participants will receive either lyophilized fecal microbiota or a placebo, and their responses will be monitored to assess the therapy's effectiveness. The study is designed for adults diagnosed with HS who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Noah Goldfarb, MD — University of Minnesota
• Study coordinator: Thomas Pritchard
• Email: pritc204@umn.edu
• Phone: 612-626-0249

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.