Examining gut microbiome changes in IBD patients with C. difficile infections
Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations
This study is trying to see how the gut bacteria of people with inflammatory bowel disease changes when they have a C. difficile infection compared to those who don't, to help understand the infection better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05714566 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the differences in gut microbiota and fecal metabolomics between patients with inflammatory bowel disease (IBD) who are infected with Clostridioides difficile and those who are not. By analyzing bacterial genera and fecal metabolites, the study seeks to identify markers that could help distinguish between these two groups and understand their implications in the pathogenesis of C. difficile infections. The study will include inpatients diagnosed with ulcerative colitis or Crohn's disease and will compare their microbiome profiles to healthy individuals without IBD or diarrhea.
Who should consider this trial
Good fit: Ideal candidates for this study are inpatients aged 18 to 75 diagnosed with ulcerative colitis or Crohn's disease.
Not a fit: Patients with diarrhea caused by other infections or those with other metabolic or inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for IBD patients at risk of C. difficile infections.
How similar studies have performed: While there is ongoing research into the gut microbiome and its implications in various diseases, this specific focus on IBD and C. difficile is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Shanghai jiaotong university, school of medicine, affliated Renji hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Min Li, professor — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Yang
- Email: 15828660135@163.com
- Phone: 13262906006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.