Clinical trial NCT04179201: Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
Official title: Study on Prevalence, Risk Factors and Intestinal Microecology of Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Clostridium Infections
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected from six hospital in China.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence rate of IBD with CDI in Chinese adults
timeFrame: 3 years
Secondary outcomes:
measure: Risk factors of IBD with CDI in China
timeFrame: 3 years
measure: Gut microbiota in patients with IBD-CDI，IBD and healthy volunteers by 16S rDNA sequencing
timeFrame: 3 years
Other outcomes:
measure: Using PCR and ELISA to detect the positive rate of clostridium difficile in patients with IBD and healthy volunteers
timeFrame: 3 years
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: Chief Professor of Xijing Hospital
name: Kaichun Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: