Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Crohn Disease Clinical Trial

Official title:

Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06146335
• Other study ID #: 23-07026235
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: December 2035

Study information

• Verified date: January 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2035
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.

2. Patients age 18 years and older.

3. All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.

4. Patients will be included regardless of preoperative medications (untreated, steroids, biologics)

Exclusion Criteria:

1. Patients under 18 years of age.

2. Pregnant patients.

3. Patient does not speak English

4. Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Procedure:
• Kono-S anastomosis (KSa)
antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery
• Side-to-side anastomosis (SSa)
side-to-side anastomosis connecting small intestine and colon after surgery

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Crohn's & Colitis Foundation of America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in composition of the microbiome between treatment groups	Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.	At the time of the surgery
Primary	Changes in the immune cell environment between treatment groups	Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.	3-6 month, 12-18 month and 60 month post-surgery endoscopy.