Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Fecal Microbiota - lyophilized; Drug: Placebo drug

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Thomas Pritchard; Phone Number: 612-626-0249; Email: pritc204@umn.edu
• Study Contact Backup: Name: Jaime Nugent; Phone Number: (612) 625-2624; Email: speck007@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Principal Investigator: Noah Goldfarb, MD
      • Contact: Thomas Pritchard; Phone Number: 612-626-0249; Email: pritc204@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent donor engraftment	Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin toxonomic relative abundances and diversity indices	Change in skin taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)	6 weeks, 12 weeks
Stool toxonomic relative abundances and diversity indices	Change in stool taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)	6 weeks, 12 weeks
Stool small chain fatty acids	Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline	12 weeks
Serum small chain fatty acids	Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline	12 weeks
Stool small molecule metabolites	change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline	6 weeks, 12 weeks
Physician-reported clinical response 1	Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR)	12 weeks
Physician-reported clinical response 2	Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55)	12 weeks
Change in IHS4	12 weeks compared to baseline	12 weeks
Change in total draining tunnel count	12 weeks compared to baseline	12 weeks
Change in the Hidradenitis Suppurativa Activity and Severity Index	12 weeks compared to baseline	12 weeks
Change in Hidradenitis Suppurativa quality of life (HiSQOL)	12 weeks compared to baseline	12 weeks
Change in Dermatology Life Quality Index (DLQI)	12 weeks compared to baseline	12 weeks
Change in skin pain numerical rating scale (NRS)	12 weeks compared to baseline	12 weeks
Change in hidradenitis suppurativa patient global assessment	12 weeks compared to baseline	12 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Noah Goldfarb, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: DERM-2023-31562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No