Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

Shandong University

Status: Active, not recruiting

Conditions: Crohn's Disease (CD)

Study type: Observational

Funder types: Other

Identifiers

NCT06895772

2025-SDU-Qilu-01

Details and patient eligibility

About

The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge gap. Additionally, this research holds significant importance for understanding the etiology of Crohn's disease and predicting treatment outcomes.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with Crohn's disease undergoing endoscopic examination
• Healthy individuals with no symptoms undergoing colonoscopy without any lesions detected
• Patients undergoing small intestinal endoscopy due to symptoms but with negative examination results.
• Age between 18 and 80 years.
• Patients or authorized family members sign the relevant informed consent forms.

Exclusion criteria

• Patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases.
• Patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases.
• Patients who have taken probiotics or antibiotics within the past week.
• Patients with psychiatric disorders or other conditions that prevent them from cooperating with the study.
• Patients participating in other clinical trials that may interfere with the results of this study.

Trial design

50 participants in 2 patient groups

CD patients

Description:

Before receiving treatment, 2-4 biopsy samples of small or large intestinal mucosa are collected from Crohn's disease patients, including both lesional and normal tissues. During follow-up endoscopy performed 3-12 months after treatment for Crohn's disease patients, either due to symptoms or routine re-examination, 2-4 pieces of small or large intestinal mucosa are collected, including both lesional and normal tissues. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing.

Healthy individuals

Description:

Collect 1-2 pieces of large or small intestinal mucosa from healthy individuals with no symptoms who undergo colonoscopy and show no lesions, or from patients who undergo small intestinal endoscopy due to symptoms but have negative examination results. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing.