Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients

Recruiting

• Conditions: Inflammatory Bowel Diseases; Clostridium Difficile Infections; Microtia
• Interventions: Diagnostic Test: Clostridioides difficile toxin detection

• Registration Number: NCT05714566
• Lead Sponsor: RenJi Hospital

Brief Summary

The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.

type of study: observational study participant population/health conditions

1. population diagnosed with Ulcerative colitis or Crohn's disease

2. Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
• age from 18 to 75 years old

Exclusion Criteria

• other infection caused diarrhea
• other metabolic diseases or inflammatory diseases
• patients who are not able to send back samples 4-6 weeks after therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD	Clostridioides difficile toxin detection	-
IBD+CDI	Clostridioides difficile toxin detection	-
Health control	Clostridioides difficile toxin detection	-

Primary Outcome Measures

Name	Time	Method
C.difficile negative	1 day	C.difficile toxin test is negative
C.difficile positive	1 day	C.difficile toxin test is positive

Trial Locations

Locations (1)

Shanghai jiaotong university, school of medicine, affliated Renji hospital; 🇨🇳 Shanghai, Shanghai, China