Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT06146335
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
Status:
COMPLETED
Status Verified Date:
2025-11
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:
The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
Detailed Description:
These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: