Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370884
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-04
Brief Title:
Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
An Open-Label Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inclusionexclusion 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None