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

Inflammatory Bowel Diseases Clinical Trial

Official title:

Study on Prevalence, Risk Factors and Intestinal Microecology of Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179201
• Other study ID #: ChiECRCT20190106
• Status: Recruiting
• Start date: September 13, 2017
• Est. completion date: September 2020

Study information

• Verified date: November 2019
• Source: Xijing Hospital
• Contact: Yujie Zhang, MD
• Phone: +8613891882872
• Email: 609183757[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Infections
• Communicable Diseases
• Infection
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Renji Hospital	Shanghai
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Using PCR and ELISA to detect the positive rate of clostridium difficile in patients with IBD and healthy volunteers	To compare the positive rate of clostridium difficile in patients with IBD and healthy volunteers by PCR and ELISA.	3 years
Primary	Prevalence rate of IBD with CDI in Chinese adults	To analyze the prevalence rate of IBD with CDI in Chinese adults based on the multicenter clinical trials.	3 years
Secondary	Risk factors of IBD with CDI in China	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.	3 years
Secondary	Gut microbiota in patients with IBD-CDI,IBD and healthy volunteers by 16S rDNA sequencing	To analyze the gut microbiota with IBD-CDI,IBD and healthy volunteers.Including fecal flora composition and the abundance analysis by 16S rDNA sequencing.	3 years