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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Clostridium Infections

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Yujie Zhang, MD; Phone Number: +8613891882872; Email: 609183757@qq.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
  • Shanghai, China
    • Recruiting
    • RenJi Hospital
    • Contact: Juntao Lu, PhD
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Xiaoqing Lin, PhD
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Tao Liu, PhD
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Yujie Zhang, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Lingna Ye, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population will be selected from six hospital in China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IBD with CDI; Inflammatory bowel disease with clostridium difficile infection
IBD without CDI; Inflammatory bowel disease without clostridium difficile infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Kaichun Wu, PhD, Chief Professor of Xijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2017
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (ACTUAL): November 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 24, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Clostridium Infections
• Other Study ID Numbers: ChiECRCT20190106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No