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

Study Overview
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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 population diagnosed with Ulcerative colitis or Crohn's disease 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.

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

Conditions
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Inflammatory Bowel Diseases, Clostridium Difficile Infections, Microtia

Intervention / Treatment
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* Diagnostic Test: Clostridioides difficile toxin detection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBD<br> | Diagnostic Test: Clostridioides difficile toxin detection<br>* 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.<br>|
| IBD+CDI<br> | Diagnostic Test: Clostridioides difficile toxin detection<br>* 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.<br>|
| Health control<br> | Diagnostic Test: Clostridioides difficile toxin detection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C.difficile positive | C.difficile toxin test is positive | 1 day | 
| C.difficile negative | C.difficile toxin test is negative | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory bowel disease, Clostridium difficile disease