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The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Maastricht University Medical Center
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01202396
First received: September 2, 2010
Last updated: September 14, 2010
Last verified: September 2010
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Purpose
Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.
| Condition |
|---|
| Pouchitis |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
In the prospective study the following biospecimens will be collected: faeces, serum, plasma, leucocytes, urine, intestinal biopsies and mucus
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
ulcerative colitis patients with a pouch
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Consecutive patients undergoing proctocolectomy with the construction of an ileal pouch anal anastomosis will be asked to participate in the study
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202396
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202396
Contacts
| Contact: D. Jonkers, PhD | *31-43-3875021 | d.jonkers@intmed.unimaas.nl | |
| Contact: M. Pierik, PhD MD | *31-43-3875021 | m.pierik@mumc.nl |
Locations
| 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 | |
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
| Principal Investigator: | A. Masclee, Prof MD PhD | Maastricht University Medical Center |
More Information
| 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 |
| Study First Received: | September 2, 2010 |
| Last Updated: | September 14, 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 |
ClinicalTrials.gov processed this record on June 26, 2017