Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

NCT06058520 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: DERM-2023-31562
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percent donor engraftment

  Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (14)

• Skin toxonomic relative abundances and diversity indices

  6 weeks, 12 weeks

• Stool toxonomic relative abundances and diversity indices

  6 weeks, 12 weeks

• Stool small chain fatty acids

  12 weeks

• Serum small chain fatty acids

  12 weeks

• Stool small molecule metabolites

  6 weeks, 12 weeks

Study Arms (2)

MMT group

EXPERIMENTAL

patients with HS randomized to receive MTT

Drug: Fecal Microbiota - lyophilized

Placebo group

PLACEBO COMPARATOR

patients with HS randomized to receive placebo treatment

Drug: Placebo drug

Interventions

Fecal Microbiota - lyophilized DRUG

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.

MMT group

Placebo drug 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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Thomas Pritchard

CONTACT

612-626-0249; pritc204@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)