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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Radboud University.
Recruitment status was  Recruiting
Dutch Cancer Society
Information provided by:
Radboud University Identifier:
First received: April 27, 2006
Last updated: August 9, 2007
Last verified: August 2007
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.

Condition Intervention Phase
Adenomatous Polyposis Coli
Drug: Sulindac (drug)
Drug: VSL#3 (probiotic)
Drug: Inulin (probiotic)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Pouch mucosal proliferation index at 0, 1 and 2 months
  • Pouch mucosal apoptosis index at 0, 1 and 2 months

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: December 2006

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00319007

Contact: Pieter Friederich, MD 00-31-24-3614760
Contact: Fokko M Nagengast, PhD 00-31-24-3614760

Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6533DD
Contact: Pieter Friederich, MD    00-31-24-3614760   
Contact: Fokko M Nagengast, PhD    00-31-24-3504066   
Principal Investigator: Pieter P Friederich, MD         
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Principal Investigator: Fokko M Nagengast, PhD Radboud University
  More Information Identifier: NCT00319007     History of Changes
Other Study ID Numbers: 23266  KUN 2003-2911 
Study First Received: April 27, 2006
Last Updated: August 9, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 22, 2016