Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

NCT ID: NCT06895772

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Crohn's Disease (CD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CD patients

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.

No interventions assigned to this group

Healthy individuals

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Director of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, doctor

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu hospital of shandong university

Jinan, Shandong, China

Countries

China

Other Identifiers

2025-SDU-Qilu-01

Identifier Type: -

Identifier Source: org_study_id