Recruiting
Early Phase 1

Microbiota Transplant

Sponsor:

University of Minnesota

Code:

NCT06058520

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota - lyophilized

Placebo drug

Study Details

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 ID

NCT06058520

Start date

Dec 27, 2023

Status verified date

Sep, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MMT group

patients with HS randomized to receive MTT

placebo comparator: Placebo group

patients with HS randomized to receive placebo treatment

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.

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.

Primary outcome measure

  • Percent donor engraftment [ Time Frame: Baseline, 6 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Thomas Pritchard

612-626-0249pritc204@umn.edu

Jaime Nugent

(612) 625-2624speck007@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Thomas Pritchard

612-626-0249pritc204@umn.edu

Principal Investigator:

Noah Goldfarb, MD

More Information

Sponsor

University of Minnesota

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-03.