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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases Clostridium Difficile Infections Microtia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IBD

Clostridioides difficile toxin detection

Intervention Type DIAGNOSTIC_TEST

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.

IBD+CDI

Clostridioides difficile toxin detection

Intervention Type DIAGNOSTIC_TEST

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.

Health control

Clostridioides difficile toxin detection

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No