Capsule microbiota transplant therapy for hidradenitis suppurativa
This study is testing whether taking a special gut treatment can help adults with hidradenitis suppurativa feel better by improving their skin condition.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | adalimumab, secukinumab, bimekizumab |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06058520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of hidradenitis suppurativa.
Not a fit: Patients who are non-English speaking, pregnant, or have specific allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients suffering from hidradenitis suppurativa, potentially improving their quality of life.
How similar studies have performed: While microbiota transplant therapies are being explored in various conditions, this specific approach for hidradenitis suppurativa is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Thomas Pritchard
- Email: pritc204@umn.edu
- Phone: 612-626-0249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.