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NCT06692179 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection
A Phase 1 study of Recurrent Clostridioides Difficile Infection and Colonic Surgery, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06692179 is a Phase 1 study of Recurrent Clostridioides Difficile Infection and Colonic Surgery that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06692179, a Phase 1 study of Recurrent Clostridioides Difficile Infection and Colonic Surgery, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to receive the investigational product. This trial will inform development of future trials in treatment of colon and rectal surgery. Active drug is composed of highly purified, freeze-dried, fecal microbiota from healthy donors. This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment. The exploratory objective is to evaluate engraftment of donor microbiota with this preparation and compare the results with data generated with the data generally from microbiota transplantation (IND28152). Stool samples may be returned via mail rather than clinic visit.
Conditions Studied
Interventions
- DRUG Orally administered preparation of fecal microbiota (MTP-101P)
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2027-02-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06692179
The ClinicalTrials.gov registry entry for NCT06692179 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Recurrent Clostridioides Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which Orally administered preparation of fecal microbiota (MTP-101P) is the first listed.
NCT06692179 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06692179 about?
NCT06692179 is a clinical study titled "An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection". This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or I...
What is the current status of trial NCT06692179?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-02-18. Estimated completion is 2027-02-18.
What conditions does trial NCT06692179 study?
This clinical trial studies the following conditions: Recurrent Clostridioides Difficile Infection, Colonic Surgery.
What interventions are being tested in trial NCT06692179?
The interventions under investigation include: Orally administered preparation of fecal microbiota (MTP-101P) (DRUG).
Who is sponsoring clinical trial NCT06692179?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06692179 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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