The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
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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
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Condition or disease |
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Pouchitis |
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
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 |
Group/Cohort |
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ulcerative colitis patients with a pouch
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- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- patients with ulcerative colitis undergoing a total colectomy with IPAA for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia
- 18-65 years of age
Exclusion Criteria:
- unable to give informed consent
- pregnant or breastfeeding

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, PhD | *31-43-3875021 | d.jonkers@intmed.unimaas.nl | |
Contact: M. Pierik, PhD MD | *31-43-3875021 | m.pierik@mumc.nl |
Netherlands | |
Maastricht University Medical Center, div. Gastroenterology-Hepatology | Not yet recruiting |
Maastricht, Limburg, Netherlands, 6226AZ | |
Contact: D. Jonkers, PhD *31-43-3875021 d.jonkers@intmed.unimaas.nl | |
Contact: M. Pierik, PhD MD *31-43-3875021 m.pierik@mumc.nl |
Principal Investigator: | A. Masclee, Prof MD PhD | Maastricht University Medical Center |
Responsible Party: | Prof. Dr. A. Masclee, Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT01202396 History of Changes |
Other Study ID Numbers: |
MEC-10-2-033 |
First Posted: | September 15, 2010 Key Record Dates |
Last Update Posted: | September 15, 2010 |
Last Verified: | September 2010 |
Keywords provided by Maastricht University Medical Center:
pouch pouchitis ulcerative colitis |
microbiota defensins epithelial integrity |
Additional relevant MeSH terms:
Pouchitis Ileitis Enteritis Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Ileal Diseases |