Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Purpose

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.

Condition

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MMT group 		patients with HS randomized to receive MTT
  • Drug: Fecal Microbiota - lyophilized
    Patients receive 2 capsules daily for one week followed by one capsule daily for 2 weeks. MTT capsules are derived from a single donor per patient.
Placebo Comparator
Placebo group 		patients with HS randomized to receive placebo treatment
  • Drug: Placebo drug
    The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55414
Contact:
Thomas Pritchard
612-626-0249
pritc204@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Thomas Pritchard
612-626-0249
pritc204@umn.edu