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NCT Number: NCT06058520

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Noah Goldfarb, MD

PRINCIPAL_INVESTIGATOR

Thomas Pritchard

CONTACT

[email protected]

612-626-0249

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percent donor engraftment

    Time frame: Baseline, 6 weeks, 12 weeks

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

Secondary outcomes

  1. Skin toxonomic relative abundances and diversity indices

    Time frame: 6 weeks, 12 weeks

    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)

  2. Stool toxonomic relative abundances and diversity indices

    Time frame: 6 weeks, 12 weeks

    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)

  3. Stool small chain fatty acids

    Time frame: 12 weeks

    Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

  4. Serum small chain fatty acids

    Time frame: 12 weeks

    Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

  5. Stool small molecule metabolites

    Time frame: 6 weeks, 12 weeks

    change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline

  6. Physician-reported clinical response 1

    Time frame: 12 weeks

    Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR)

  7. Physician-reported clinical response 2

    Time frame: 12 weeks

    Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55)

  8. Change in IHS4

    Time frame: 12 weeks

    12 weeks compared to baseline

  9. Change in total draining tunnel count

    Time frame: 12 weeks

    12 weeks compared to baseline

  10. Change in the Hidradenitis Suppurativa Activity and Severity Index

    Time frame: 12 weeks

    12 weeks compared to baseline

  11. Change in Hidradenitis Suppurativa quality of life (HiSQOL)

    Time frame: 12 weeks

    12 weeks compared to baseline

  12. Change in Dermatology Life Quality Index (DLQI)

    Time frame: 12 weeks

    12 weeks compared to baseline

  13. Change in skin pain numerical rating scale (NRS)

    Time frame: 12 weeks

    12 weeks compared to baseline

  14. Change in hidradenitis suppurativa patient global assessment

    Time frame: 12 weeks

    12 weeks compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Pritchard

CONTACT

[email protected]

612-626-0249

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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