Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

NCT ID: NCT06058520

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MMT group

patients with HS randomized to receive MTT

Group Type: EXPERIMENTAL

Fecal Microbiota - lyophilized

Intervention Type: 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.

Placebo group

patients with HS randomized to receive placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo drug

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Irmina Wallander

Role: CONTACT

Phone: 612-624-5721

Email: wall0396@umn.edu

Facility Contacts

Irmina Wallander

Role: primary

Other Identifiers

DERM-2023-31562

Identifier Type: -

Identifier Source: org_study_id