RECRUITING

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Quick Facts

Study Start:2023-10-01

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06058520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Irmina Wallander

CONTACT

612-624-5721

wall0396@umn.edu

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2023-10-01

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa