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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202396
First Posted: September 15, 2010
Last Update Posted: September 15, 2010
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.
Information provided by:
Maastricht University Medical Center
  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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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
  • ulcerative colitis patients undergoing proctocolectomy with an ileal pouch anal anastomosis
  • comparing patients with versus those without pouchitis
  • no intervention

  Eligibility

Information from the National Library of Medicine

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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
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
Information from the National Library of Medicine

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


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
First Submitted: September 2, 2010
First Posted: September 15, 2010
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