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NCT06058520 · ClinicalTrials.gov registry record · Early Phase 1
Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
A Early Phase 1 study of Hidradenitis Suppurativa, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06058520: Recruiting Early Phase 1 study of Hidradenitis Suppurativa, sponsored by University of Minnesota.
NCT06058520 is a Early Phase 1 study of Hidradenitis Suppurativa that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 16 participants, below the 598-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06058520, a Early Phase 1 study of Hidradenitis Suppurativa, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
Conditions Studied
Interventions
- DRUG Fecal Microbiota - lyophilized
- DRUG Placebo drug
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2026-09-01 |
| Phase | Early Phase 1 |
What NCT06058520 shows while recruiting
NCT06058520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 598-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions - of which Fecal Microbiota - lyophilized is the first listed.
NCT06058520 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06058520 about?
NCT06058520 is a clinical study titled "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 an...
What is the current status of trial NCT06058520?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2023-10-01. Estimated completion is 2026-09-01.
What conditions does trial NCT06058520 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT06058520?
The interventions under investigation include: Fecal Microbiota - lyophilized (DRUG), Placebo drug (DRUG).
Who is sponsoring clinical trial NCT06058520?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06058520 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06058520's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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