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

Phase 2UnknownNCT00319007

Radboud University Medical Center30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Adenomatous Polyposis Coli

Interventions

Sulindac (drug)DRUG

VSL#3 (probiotic)DRUG

Inulin (probiotic)DRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

RECRUITING

Outcomes

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

Central Contacts

Pieter Friederich, MD

CONTACT

00-31-24-3614760 P.Friederich@mdl.umcn.nl

Fokko M Nagengast, PhD

CONTACT

00-31-24-3614760 F.Nagengast@mdl.umcn.nl

Data from ClinicalTrials.gov

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