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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: Recruiting Phase 1 study of Recurrent Clostridioides Difficile Infection and Colonic Surgery, sponsored by University of Minnesota.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
(via alpha and beta diversity statistics) essentially compares the study patient's microbiome composition at any time point when stool is collected to the microbiome composition of the donor fecal transplant that the study patient receives. Before receiving the fecal transplant, we do not expect the study patient's microbiome composition to mirror the donor. However, after giving the donor fecal transplant, we expect the study patient's microbiome composition to look similar to the transplant th
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 |
What NCT06692179 shows while recruiting
NCT06692179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06692179's enrollment target sits among peer trials
40 1131st of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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