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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

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

Trial Description

Summary

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, PhDPrincipal Investigator

Pieter Friederich, MDPh: 00-31-24-3614760
  Email: P.Friederich@mdl.umcn.nl

Trial Sites

Netherlands
  Nijmegen
 Universitair Medisch Centrum St. Radboud - Nijmegen
 Pieter Friederich, MD Ph: 00-31-24-3614760
  Email: P.Friederich@mdl.umcn.nl
 Fokko M Nagengast, PhD Ph: 00-31-24-3504066
  Email: F.Nagengast@mdl.umcn.nl
 Pieter P Friederich, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00319007
ClinicalTrials.gov processed this data on October 17, 2013

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

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