Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn’s Disease

Overview

In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.

Full Title of Study: “Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn’s Disease”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: March 15, 2023

Arms, Groups and Cohorts

• Before ileocecal resection
  • Patients diagnosed with Crohn’s disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients were admitted for right hemicolectomy
• After ileocecal resection
  • Patients diagnosed with Crohn’s disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients underwent reversal of ileostoma after right hemicolectomy

Clinical Trial Outcome Measures

Primary Measures

• Microbial changes of intestinal mucosa
  • Time Frame: 6 month
  • Explore the microbial changes in the mucosa of the terminal ileum and the middle segment of the ascending colon in patients with Crohn’s disease before and after ileocecal resection through metagenomic analysis

Secondary Measures

• Microbial changes of mesenteric adipose tissue
  • Time Frame: 6 month
  • Explore the microbial changes in the mesenteric adipose tissue of the terminal ileum and the middle segment of the ascending colon in patients with Crohn’s disease before and after ileocecal resection through metagenomic analysis

Participating in This Clinical Trial

Inclusion Criteria

Clinical diagnosis of Crohn's disease Exclusion Criteria:

Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Shanghai 10th People’s Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Huanlong Qin, Professor – Shanghai 10th People’s Hospital
• Overall Contact(s)
  • Kai Xia, MM, 13588251107, 987239945@qq.com