Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Status Enrolling by invitation

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Crohn Disease

Clinical Trial Details

NCT number	NCT06146335
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	January 3, 2024
Completion date	December 2035

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04046913` - The ADDapt Diet in Reducing Crohn's Disease Inflammation	N/A
Recruiting	`NCT05169593` - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy	Phase 4
Recruiting	`NCT06116604` - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT05627128` - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease	N/A
Recruiting	`NCT05294107` - Intestinal Organoids	N/A
Withdrawn	`NCT04349449` - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed	`NCT03058679` - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease	N/A
Completed	`NCT02871635` - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity	Phase 3
Recruiting	`NCT04539665` - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.	N/A
Recruiting	`NCT04266600` - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease	N/A
Recruiting	`NCT03913572` - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed	`NCT03668249` - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed	`NCT03606499` - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Terminated	`NCT04102111` - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease	Phase 2
Recruiting	`NCT04997733` - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal	Phase 3
Recruiting	`NCT05906576` - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients	Phase 4
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3
Not yet recruiting	`NCT04502303` - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease	Phase 2