Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

Analysis of Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With Crohn's Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn's Disease (CD)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

CD patients or healthy individuals

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast the characteristics of the intestinal microbiota in Crohn's disease and healthy individuals	Compare the differences in the microbiota within the intestinal mucosal tissue between patients with Crohn's disease and healthy individuals	12 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Director: Xiuli Zuo, doctor, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Estimated): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-SDU-Qilu-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No