Psoriasis Clinical Trial

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

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 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 is only one currently FDA-approved treatment, adalimumab, but 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

16

Study ID:

NCT06058520

Recruitment Status:

Recruiting

Sponsor:

University of Minnesota

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There is 1 Location for this study

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University of Minnesota
Minneapolis Minnesota, 55414, United States More Info
Gretchen Bellefeuille
Contact
612-626-0249
[email protected]
Noah Goldfarb, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

16

Study ID:

NCT06058520

Recruitment Status:

Recruiting

Sponsor:


University of Minnesota

How clear is this clinincal trial information?

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