Inflammatory Bowel DiseasesNCT04179201
Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Clostridium Infections, run by Xijing Hospital at 6 sites in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Clostridium Infections
- How many people
- 1,000 participants
- Where
- 6 sitesChina
- Study dates
- 13 Sep 2017to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population will be selected from six hospital in China.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yue Li, PhD
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Xiaoqing Lin, PhD
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Tao Liu, PhD
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Lingna Ye, PhD
- Recruiting
Renji Hospital
Shanghai
Juntao Lu, PhD
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Yujie Zhang, MD
About this study
Official title: 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:
- To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..
- To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.
- To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.
- Medical subject headings
- Inflammatory Bowel Diseases, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD with CDI | Inflammatory bowel disease with clostridium difficile infection | |
| IBD without CDI | Inflammatory bowel disease without clostridium difficile infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start13 Sep 2017
- Primary completionJan 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, PhD, Principal investigator, Chief Professor of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179201
- Sponsor's protocol ID
- ChiECRCT20190106
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Prevalence, Risk Factors and Intestinal Microecology of Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04179201
- Acronym / sponsor ID
- ChiECRCT20190106
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials..
- To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials.
- To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD with CDI | – | –Inflammatory bowel disease with clostridium difficile infection |
| IBD without CDI | – | –Inflammatory bowel disease without clostridium difficile infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will be selected from six hospital in China.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence rate of IBD with CDI in Chinese adults
Time frame: 3 years
To analyze the prevalence rate of IBD with CDI in Chinese adults based on the multicenter clinical trials.
2 secondary outcomes
Risk factors of IBD with CDI in China
Time frame: 3 years
Gut microbiota in patients with IBD-CDI，IBD and healthy volunteers by 16S rDNA sequencing
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaichun Wu, PhD principal investigator
Chief Professor of Xijing Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Clostridium Infections, run by Xijing Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Zhang, MD (+8613891882872, 609183757@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence rate of IBD with CDI in Chinese adults (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.