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The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis

NCT ID: NCT01202396

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pouchitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center

Principal Investigators

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A. Masclee, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center, div. Gastroenterology-Hepatology

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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D. Jonkers, PhD

Role: CONTACT

[email protected]
*31-43-3875021

M. Pierik, PhD MD

Role: CONTACT

[email protected]
*31-43-3875021

Facility Contacts

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D. Jonkers, PhD

Role: primary

[email protected]
*31-43-3875021

M. Pierik, PhD MD

Role: backup

[email protected]
*31-43-3875021

Other Identifiers

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MEC-10-2-033

Identifier Type: -

Identifier Source: org_study_id