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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. The completion date has passed and the status has not been verified in more than two years.
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
Intervention Model: Crossover Assignment
Masking: None (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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic processed this record on September 21, 2017