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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionActive16 and overOther23266
KUN 2003-2911, NCT00319007

Trial Description


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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Universitair Medisch Centrum St. Radboud - Nijmegen

  • Dutch Cancer Society
Fokko M Nagengast, PhD, Principal Investigator
Pieter Friederich, MD
Ph: 00-31-24-3614760

Trial Sites



Universitair Medisch Centrum St. Radboud - Nijmegen

Pieter Friederich, MD
Ph: 00-31-24-3614760

Fokko M Nagengast, PhD
Ph: 00-31-24-3504066

Pieter P Friederich, MD
Principal Investigator

Link to the current record.
NLM Identifier NCT00319007 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to