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

Radboud University Medical Center

Status and phase: Unknown; Phase 2

Conditions: Adenomatous Polyposis Coli

Treatments: Drug: VSL#3 (probiotic); Drug: Inulin (probiotic); Drug: Sulindac (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00319007

23266

KUN 2003-2911

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)