- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768038
Intestinal Microbiome and Chronic Inflammatory Bowel Disease
June 26, 2019 updated by: Turku University Hospital
The Role of Intestinal Microbiome ih the Pathogenesis and Course of Chronic Inflammatory Bowel Diseases
The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)
Study Overview
Detailed Description
IBD patients to whom colonoscopy is performed will be recruited.
Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens.
The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Turku, Finland, 20521
- Recruiting
- Turku University Hospital
-
Contact:
- Markku E Voutilainen, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with IBD living at the Turku University Hospital area
Description
Inclusion Criteria:
- IBD
Exclusion Criteria:
- patient refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of microbiome in chronic inflammatory bowel disease
Time Frame: 5 yrs
|
5 yrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markku Voutilainen, Prof., Head, Department of Gastroenterology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
December 16, 2015
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Actual)
June 27, 2019
Last Update Submitted That Met QC Criteria
June 26, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TurkuUH2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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