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

NCT05714566 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Clostridium Difficile Infections
  • Microtia

Interventions

DIAGNOSTIC_TEST

Clostridioides difficile toxin detection

Using Genexpert kit to detect the stool samples of IBD patients. If C. difficile toxin is positive, the patient is assigned to IBD+CDI group, or else assigned to IBD group. Every sample assigned to Health control group should have negative results for C.difficile toxin tests.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Min Li, professor · Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2024-06-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714566 on ClinicalTrials.gov