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NCT06197308 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
A Early Phase 1 study of Primary Sclerosing Cholangitis, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06197308: Recruiting Early Phase 1 study of Primary Sclerosing Cholangitis, sponsored by University of Minnesota.
NCT06197308 is a Early Phase 1 study of Primary Sclerosing Cholangitis that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 28 participants, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06197308, a Early Phase 1 study of Primary Sclerosing Cholangitis, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.
Primary Outcome
Determine the frequency of serious adverse events and other adverse events
Conditions Studied
Interventions
- DRUG oral vancomycin and oral amoxicillin
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2027-09-01 |
| Phase | Early Phase 1 |
What NCT06197308 shows while recruiting
NCT06197308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 1 intervention - of which oral vancomycin and oral amoxicillin is the first listed.
NCT06197308 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06197308 about?
NCT06197308 is a clinical study titled "Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC". This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.
What is the current status of trial NCT06197308?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2024-03-01. Estimated completion is 2027-09-01.
What conditions does trial NCT06197308 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT06197308?
The interventions under investigation include: oral vancomycin and oral amoxicillin (DRUG).
Who is sponsoring clinical trial NCT06197308?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06197308 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 NCT06197308's enrollment target sits among peer trials
28 18th of 23 higher than 5 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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