Clinical Trial: Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemopreven
Brief 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.
Detailed Summary:
Sponsor: Radboud University
Current Primary Outcome:
- Pouch mucosal proliferation index at 0, 1 and 2 months
- Pouch mucosal apoptosis index at 0, 1 and 2 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
- Faecal genotoxicity at 0, 1 and 2 months
- Faecal cytotoxicity at 0, 1 and 2 months
Original Secondary Outcome: Same as current
Information By: Radboud University
Dates:
Date Received: April 27, 2006
Date Started: April 2006
Date Completion: December 2006
Last Updated: August 9, 2007
Last Verified: August 2007