Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

NCT06895772 | Active Not Recruiting

• 1 other identifier: 2025-SDU-Qilu-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• The characteristics of the intestinal microbiota in Crohn's disease

  Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with Crohn's disease；Analyze the differences in the microbiota between the lesional and normal intestinal mucosal tissues of patients with Crohn's disease；Analyze the differences in the microbiota within the intestinal mucosal tissue of patients with Crohn's disease before and after treatment.

  12 months

Secondary Outcomes (1)

• Contrast the characteristics of the intestinal microbiota in Crohn's disease and healthy individuals

  12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CD patients or healthy individuals

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital of shandong university

Jinan, Shandong, 250012, China

Location

Study Officials

• Xiuli Zuo, doctor

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Department

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 26, 2025
• Study Start: November 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)