Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease

• Conditions: Inflammatory Bowel Diseases; Clostridium Infections

• Registration Number: NCT04179201
• Lead Sponsor: Xijing Hospital

Brief Summary

In recent years, the incidence of Inflammatory Bowel Disease (IBD) has been increasing in China, which poses great challenges and burdens to the medical community due to its unknown etiology, recurrence and incurability. Co-infection is one of the important causes in IBD development. IBD accompanied with Clostridium Difficile Infection (CDI) can significantly decrease the treatment efficiency, leading to increased surgical rate, increased mortality, prolonged hospital stay, and increased hospital costs. Recently, several Chinese clinical guidelines about IBD or CDI have been published, but these guidelines are mainly based on the foreign studies. Compared with the developed countries, the lack of multi-center, large-scale and multi-test clinical trials and cohort studies caused limited understanding for IBD-CDI in China. Therefore, it is of great importance to carry out the multi-center clinical trials and analysis on IBD-CDI to improve the diagnostic and therapeutic efficiency in IBD-CDI patients

Objective:

1. To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..

2. To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.

3. To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-13
• Status Verified: 2019-11
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-24
• Last Update Submitted: 2019-11-24
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Primary Completion: 2020-01
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 1.Inpatients with diagnostic criteria for ulcerative colitis and Crohn's disease in accordance with the consensus opinion on the diagnosis and treatment of inflammatory bowel disease in China in 2012
• 2.Willing to participate in the study;
• 3. Have the ability to understand and sign informed consent.

Exclusion Criteria

• 1.Patients with infectious enteritis, intestinal tuberculosis, lymphoma, Behcet's disease or other intestinal diseases except inflammatory bowel disease;
• 2.Pregnant or lactating women;
• 3.Severe circulatory system, respiratory system, blood system, immune system, urinary system and other combined diseases or serious psychosomatic diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence rate of IBD with CDI in Chinese adults	3 years	To analyze the prevalence rate of IBD with CDI in Chinese adults based on the multicenter clinical trials.

Secondary Outcome Measures

Name	Time	Method
Gut microbiota in patients with IBD-CDI，IBD and healthy volunteers by 16S rDNA sequencing	3 years	To analyze the gut microbiota with IBD-CDI，IBD and healthy volunteers.Including fecal flora composition and the abundance analysis by 16S rDNA sequencing.
Risk factors of IBD with CDI in China	3 years	To analyze the related risk factors of IBD with CDI in China based on the multicenter clinical trials. Including demographic data,severity of disease（Mayo score for ulcerative colitis and CDAI score for CD),laboratory results（ESR、CRP、WBC、Hb、RBC）and combination therapy.

Trial Locations

Locations (6)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Renji Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China