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

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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: 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 9, 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