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
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00319007
First received: April 27, 2006
Last updated: August 9, 2007
Last verified: August 2007
  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.


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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00319007

Contacts
Contact: Pieter Friederich, MD 00-31-24-3614760 P.Friederich@mdl.umcn.nl
Contact: Fokko M Nagengast, PhD 00-31-24-3614760 F.Nagengast@mdl.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6533DD
Contact: Pieter Friederich, MD    00-31-24-3614760    P.Friederich@mdl.umcn.nl   
Contact: Fokko M Nagengast, PhD    00-31-24-3504066    F.Nagengast@mdl.umcn.nl   
Principal Investigator: Pieter P Friederich, MD         
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Investigators
Principal Investigator: Fokko M Nagengast, PhD Radboud University
  More Information

No publications provided

ClinicalTrials.gov 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:
Adenoma
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Sulindac
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on July 23, 2014