Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Phase 2
- Conditions
- Adenomatous Polyposis Coli
- Registration Number
- NCT00319007
- Lead Sponsor
- Radboud University Medical Center
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pouch mucosal proliferation index at 0, 1 and 2 months Pouch mucosal apoptosis index at 0, 1 and 2 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands