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


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.

Full Title of Study: “Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2023


  • 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.

Arms, Groups and Cohorts

  • IBD
  • Health control

Clinical Trial Outcome Measures

Primary Measures

  • C.difficile positive
    • Time Frame: 1 day
    • C.difficile toxin test is positive
  • C.difficile negative
    • Time Frame: 1 day
    • C.difficile toxin test is negative

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Min Li, professor, Principal Investigator, Shanghai Jiao Tong University School of Medicine
  • Overall Contact(s)
    • Yang, 13262906006,

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