Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Overview
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.
Full Title of Study: “Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
Interventions
- Drug: Sulindac (drug)
- Drug: VSL#3 (probiotic)
- Drug: Inulin (probiotic)
Clinical Trial Outcome Measures
Primary Measures
- Pouch mucosal proliferation index at 0, 1 and 2 months
- Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Radboud University Medical Center
- Collaborator
- Dutch Cancer Society
- Overall Official(s)
- Fokko M Nagengast, PhD, Principal Investigator, Radboud University Medical Center
- Overall Contact(s)
- Pieter Friederich, MD, 00-31-24-3614760, P.Friederich@mdl.umcn.nl
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