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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05714566
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12.8
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Clostridium Difficile Infections; Microtia	Diagnostic Test: Clostridioides difficile toxin detection

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations
• Actual Study Start Date: Nov 7, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
IBD	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.
IBD+CDI	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.
Health control	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.

Outcome Measures

Primary Outcome Measures

1. C.difficile positive [1 day]

   C.difficile toxin test is positive

2. C.difficile negative [1 day]

   C.difficile toxin test is negative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai jiaotong university, school of medicine, affliated Renji hospital	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• RenJi Hospital

Investigators

• Principal Investigator: Min Li, professor, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT05714566
• Other Study ID Numbers: LY2022-059-B
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RenJi Hospital: Inflammatory bowel disease; Clostridium difficile disease
• Additional relevant MeSH terms: Infections; Clostridium Infections; Intestinal Diseases; Inflammatory Bowel Diseases; Congenital Microtia

Study Results

No Results Posted as of Feb 6, 2023