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

Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05714566
Enrollment
100
Registered
2023-02-06
Start date
2022-11-07
Completion date
2024-12-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infections, Inflammatory Bowel Diseases, Microtia

Keywords

Inflammatory bowel disease, Clostridium difficile disease

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.

Interventions

DIAGNOSTIC_TESTClostridioides 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

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
C.difficile positive1 dayC.difficile toxin test is positive
C.difficile negative1 dayC.difficile toxin test is negative

Countries

China

Contacts

Primary ContactYang
15828660135@163.com13262906006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026