The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01202396|
Recruitment Status : Unknown
Verified September 2010 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 15, 2010
Last Update Posted : September 15, 2010
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||The Interaction Between the Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis: a Multifactorial Approach|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2015|
ulcerative colitis patients with a pouch
- Differences in the intestinal microbiota composition between pouch patients with and without pouchitis [ Time Frame: 24 months. ]A phylogenetic microarray will be used to characterize the luminal and mucosal microbiota composition (based on the SSU rRNA gene)of pouch patients with and without pouchitis. Anticipated results are the identification of specific bacterial profiles, genera and/or species dat are discriminating between subgroups.
- The expression of defensins in the intestinal mucosa [ Time Frame: 24 months ]The mRNA expression levels of human alfa and beta-defensins in intestinal mucosal biopsies will be assessed by real time PCR
- The intestinal permeability [ Time Frame: 24 months. ]The epithelial integrity will be studied by the multiple sugar test to assess small intestinal and whole gut permeability.
- Inflammatory mediators [ Time Frame: 24 months ]Cytokine levels will be studied in serum and in intestinal biopsies. Furthermore, a histological evaluation and the MPO activity will be studied in these biopsies and calprotectin levels will be determined in 'fecal' sampels.
- The expression of tight-junction associated proteins [ Time Frame: 24 months. ]The intestinal tight junctions-associated proteins will be studied by immune staining of intestinal biopsies and mRNA levels in intestinal biopsies using real time PCR. Biopsies will be collected from standardised locations.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202396
|Contact: D. Jonkers, PhDemail@example.com|
|Contact: M. Pierik, PhD MDfirstname.lastname@example.org|
|Maastricht University Medical Center, div. Gastroenterology-Hepatology||Not yet recruiting|
|Maastricht, Limburg, Netherlands, 6226AZ|
|Contact: D. Jonkers, PhD *31-43-3875021 email@example.com|
|Contact: M. Pierik, PhD MD *31-43-3875021 firstname.lastname@example.org|
|Principal Investigator:||A. Masclee, Prof MD PhD||Maastricht University Medical Center|