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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Clostridium Difficile Infections; Microtia; Inflammatory Bowel Diseases

Treatments: Diagnostic Test: Clostridioides difficile toxin detection

Study type: Observational

Funder types: Other

Identifiers

NCT05714566

LY2022-059-B

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

IBD

Treatment:

Diagnostic Test: Clostridioides difficile toxin detection

IBD+CDI

Treatment:

Diagnostic Test: Clostridioides difficile toxin detection

Health control

Treatment:

Diagnostic Test: Clostridioides difficile toxin detection