Clinical trial NCT06058520: Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
Official title: Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an exploratory, randomized, double blind, placebo- controlled clinical trial. Subjects and investigators will be blinded to the Microbiota transplant therapy (MTT) and placebo arms.
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Percent donor engraftment
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Skin toxonomic relative abundances and diversity indices
timeFrame: 6 weeks, 12 weeks
measure: Stool toxonomic relative abundances and diversity indices
timeFrame: 6 weeks, 12 weeks
measure: Stool small chain fatty acids
timeFrame: 12 weeks
measure: Serum small chain fatty acids
timeFrame: 12 weeks
measure: Stool small molecule metabolites
timeFrame: 6 weeks, 12 weeks
measure: Physician-reported clinical response 1
timeFrame: 12 weeks
measure: Physician-reported clinical response 2
timeFrame: 12 weeks
measure: Change in IHS4
timeFrame: 12 weeks
measure: Change in total draining tunnel count
timeFrame: 12 weeks
measure: Change in the Hidradenitis Suppurativa Activity and Severity Index
timeFrame: 12 weeks
measure: Change in Hidradenitis Suppurativa quality of life (HiSQOL)
timeFrame: 12 weeks
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: 12 weeks
measure: Change in skin pain numerical rating scale (NRS)
timeFrame: 12 weeks
measure: Change in hidradenitis suppurativa patient global assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: