Status:
UNKNOWN
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Adenomatous Polyposis Coli
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Clinically or genetically proven familial adenomatous polyposis
- Restorative proctocolectomy with ileal pouch anal anastomosis
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00319007
Start Date
April 1 2006
End Date
December 1 2006
Last Update
August 10 2007
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6533DD