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

study id #: NCT00319007

condition: Adenomatous Polyposis Coli

status: status unknown

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.

intervention:
Drug: Sulindac (drug)
Drug: VSL#3 (probiotic)
Drug: Inulin (probiotic)

start date: April 2006

estimated completion: December 2006

last updated: August 10, 2007

phase of development: Phase 2

size / enrollment: 30

study design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

primary outcomes:

• Pouch mucosal proliferation index at 0, 1 and 2 months
  
• Pouch mucosal apoptosis index at 0, 1 and 2 months

secondary outcomes:

• 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

inclusion criteria:

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

sponsor: Radboud University

investigators: Fokko M Nagengast, PhD

trial center locations: Netherlands