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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: unknown
purpose: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:
- 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
sponsor: Radboud University
contacts: Pieter Friederich, MD; 00-31-24-3614760; P.Friederich@mdl.umcn.nl
Fokko M Nagengast, PhD; 00-31-24-3614760; F.Nagengast@mdl.umcn.nl
investigators: Fokko M Nagengast, PhD
locations: Netherlands
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