NCT04179201

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. 1.To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..
  2. 2.To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.
  3. 3.To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

November 22, 2019

Last Update Submit

November 24, 2019

Conditions

Inflammatory Bowel DiseasesClostridium Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Risk factors of IBD with CDI in China

    3 years

  • Gut microbiota in patients with IBD-CDI，IBD and healthy volunteers by 16S rDNA sequencing

    3 years

Other Outcomes (1)

  • Using PCR and ELISA to detect the positive rate of clostridium difficile in patients with IBD and healthy volunteers

    3 years

Study Arms (2)

IBD with CDI

Inflammatory bowel disease with clostridium difficile infection

IBD without CDI

Inflammatory bowel disease without clostridium difficile infection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will be selected from six hospital in China.

You may qualify if:

  • 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
  • Willing to participate in the study;
  • \. Have the ability to understand and sign informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Renji Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collecting stool samples from subjects

MeSH Terms

Conditions

Inflammatory Bowel DiseasesClostridium Infections

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Kaichun Wu, PhD

    Chief Professor of Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Zhang, MD

CONTACT

+8613891882872609183757@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 27, 2019

Study Start

September 13, 2017

Primary Completion

January 1, 2020

Study Completion

September 1, 2020

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

CN(6)