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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD with CDI | Inflammatory bowel disease with clostridium difficile infection | ||
| IBD without CDI | Inflammatory bowel disease without clostridium difficile infection |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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The population will be selected from six hospital in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujie Zhang, MD | Contact | +8613891882872 | 609183757@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Kaichun Wu, PhD | Chief Professor of Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Collecting stool samples from subjects
| 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 |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|
| Renji Hospital | Recruiting | Shanghai | China |
|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |