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NCT06370884 · ClinicalTrials.gov registry record · Phase 1
Intestinal Microbiota Transplantation 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
NCT06370884 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
NCT06370884, 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 is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).
Conditions Studied
Interventions
- DRUG IMT
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06370884
The ClinicalTrials.gov registry entry for NCT06370884 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 IMT is the first listed.
NCT06370884 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06370884 about?
NCT06370884 is a clinical study titled "Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection". This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and recei...
What is the current status of trial NCT06370884?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-02-01. Estimated completion is 2026-08-01.
What conditions does trial NCT06370884 study?
This clinical trial studies the following conditions: Recurrent Clostridioides Difficile Infection, Colonic Surgery.
What interventions are being tested in trial NCT06370884?
The interventions under investigation include: IMT (DRUG).
Who is sponsoring clinical trial NCT06370884?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06370884 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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