Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo drug; Drug: Fecal Microbiota - lyophilized

Study type: Interventional

Funder types: Other

Identifiers

NCT06058520

DERM-2023-31562

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

MMT group

Experimental group

Description:

patients with HS randomized to receive MTT

Treatment:

Drug: Fecal Microbiota - lyophilized

Placebo group

Placebo Comparator group

Description:

patients with HS randomized to receive placebo treatment

Treatment:

Drug: Placebo drug