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