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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714566
• Other study ID #: LY2022-059-B
• Status: Recruiting
• Start date: November 7, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Yang
• Phone: 13262906006
• Email: 15828660135[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Clostridium Infections
• Infections
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Microtia

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai jiaotong university, school of medicine, affliated Renji hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C.difficile positive	C.difficile toxin test is positive	1 day
Primary	C.difficile negative	C.difficile toxin test is negative	1 day