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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Fecal Microbiota - lyophilized
  • DRUG Placebo drug

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2023-10-01
Est. Completion 2026-09-01
Phase Early Phase 1

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT06058520

The ClinicalTrials.gov registry entry for NCT06058520 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 598-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (97% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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