Hidradenitis SuppurativaEarly Phase 1NCT06058520
Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
A Early Phase 1 study testing Fecal Microbiota - lyophilized in people with Hidradenitis Suppurativa, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Fecal Microbiota - lyophilized
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Thomas Pritchard, 612-626-0249, pritc204@umn.edu
Noah Goldfarb, MD
About this study
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
- Being tested
- Fecal Microbiota - lyophilized, Placebo drug
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota - lyophilizedDrug
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 drugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MMT group | Experimental | patients with HS randomized to receive MTT Receives: Drug: Fecal Microbiota - lyophilized |
| Placebo group | Placebo comparator | patients with HS randomized to receive placebo treatment Receives: Drug: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent donor engraftment
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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
Measured: 12 weeks
Serum small chain fatty acids
Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Measured: 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
Measured: 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)
Measured: 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)
Measured: 12 weeks
Change in IHS4
12 weeks compared to baseline
Measured: 12 weeks
Change in total draining tunnel count
12 weeks compared to baseline
Measured: 12 weeks
Change in the Hidradenitis Suppurativa Activity and Severity Index
12 weeks compared to baseline
Measured: 12 weeks
Change in Hidradenitis Suppurativa quality of life (HiSQOL)
12 weeks compared to baseline
Measured: 12 weeks
Change in Dermatology Life Quality Index (DLQI)
12 weeks compared to baseline
Measured: 12 weeks
Change in skin pain numerical rating scale (NRS)
12 weeks compared to baseline
Measured: 12 weeks
Change in hidradenitis suppurativa patient global assessment
12 weeks compared to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start27 Dec 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noah Goldfarb, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058520
- Sponsor's protocol ID
- DERM-2023-31562
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06058520
- Acronym / sponsor ID
- DERM-2023-31562
- Conditions
- Hidradenitis Suppurativa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MMT group | Experimental | Drug: Fecal Microbiota - lyophilizedpatients with HS randomized to receive MTT |
| Placebo group | Placebo comparator | Drug: Placebo drugpatients with HS randomized to receive placebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota - lyophilizedPatients 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. | Drug | MMT group |
| Placebo drugThe 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. | Drug | Placebo group |
Primary outcome
Percent donor engraftment
Time frame: Baseline, 6 weeks, 12 weeks
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
14 secondary outcomes
Skin toxonomic relative abundances and diversity indices
Time frame: 6 weeks, 12 weeks
Stool toxonomic relative abundances and diversity indices
Time frame: 6 weeks, 12 weeks
Stool small chain fatty acids
Time frame: 12 weeks
Serum small chain fatty acids
Time frame: 12 weeks
Stool small molecule metabolites
Time frame: 6 weeks, 12 weeks
Physician-reported clinical response 1
Time frame: 12 weeks
Physician-reported clinical response 2
Time frame: 12 weeks
Change in IHS4
Time frame: 12 weeks
Change in total draining tunnel count
Time frame: 12 weeks
Change in the Hidradenitis Suppurativa Activity and Severity Index
Time frame: 12 weeks
Change in Hidradenitis Suppurativa quality of life (HiSQOL)
Time frame: 12 weeks
Change in Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks
Change in skin pain numerical rating scale (NRS)
Time frame: 12 weeks
Change in hidradenitis suppurativa patient global assessment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noah Goldfarb, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fecal Microbiota - lyophilized in people with Hidradenitis Suppurativa, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Pritchard (612-626-0249, pritc204@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent donor engraftment (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.