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Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Prevention

Active

16 and over

Other

23266
KUN 2003-2911, NCT00319007

Trial Description

Summary

The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.

Eligibility Criteria

Inclusion Criteria:

Clinically or genetically proven familial adenomatous polyposis

Restorative proctocolectomy with ileal pouch anal anastomosis

Exclusion Criteria:

Chronic or acute renal or hepatic disease

History of oesophageal, gastric or duodenal ulcers

Known hypersensitivity to sulindac

Daily use during the last three months of:

Aspirin

Non-Steroidal Anti-Inflammatory Agents

Probiotics

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitair Medisch Centrum St. Radboud - Nijmegen

Dutch Cancer Society

Fokko M Nagengast, PhD

Principal Investigator

Pieter Friederich, MD		Ph: 00-31-24-3614760
		Email: P.Friederich@mdl.umcn.nl

Fokko M Nagengast, PhD		Ph: 00-31-24-3614760
		Email: F.Nagengast@mdl.umcn.nl

Trial Sites

Netherlands

Nijmegen

Universitair Medisch Centrum St. Radboud - Nijmegen

Pieter Friederich, MD Ph: 00-31-24-3614760

Email: P.Friederich@mdl.umcn.nl

Fokko M Nagengast, PhD Ph: 00-31-24-3504066

Email: F.Nagengast@mdl.umcn.nl

Pieter P Friederich, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00319007
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.