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

NCT05714566 | Unknown

• 1 other identifier: LY2022-059-B
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.population diagnosed with Ulcerative colitis or Crohn's disease
2. 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.

Conditions

Inflammatory Bowel Diseases; Clostridium Difficile Infections; Microtia

Keywords

Inflammatory bowel disease; Clostridium difficile disease

Outcome Measures

Primary Outcomes (2)

• C.difficile positive

  C.difficile toxin test is positive

  1 day

• C.difficile negative

  C.difficile toxin test is negative

  1 day

Study Arms (3)

IBD

Diagnostic Test: Clostridioides difficile toxin detection

IBD+CDI

Diagnostic Test: Clostridioides difficile toxin detection

Health control

Diagnostic Test: Clostridioides difficile toxin detection

Interventions

Clostridioides difficile toxin detection 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; IBD; IBD+CDI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. IBD group: inpatients diagnosed with ulcerative colitis or Crohn's disease. 2. IBD+CDI group: IBD patients positive for C.difficile toxin and having diarrhea 3. Health control: people without diarrhea or any other intestinal diseases and negative for C.difficile toxin tests

You may qualify if:

• inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
• age from 18 to 75 years old

You may not qualify if:

• other infection caused diarrhea
• other metabolic diseases or inflammatory diseases
• patients who are not able to send back samples 4-6 weeks after therapy

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai jiaotong university, school of medicine, affliated Renji hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections; Congenital Microtia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Min Li, professor

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang

CONTACT

13262906006; 15828660135@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: November 7, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)