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
Recruitment status was Recruiting
Sponsor:
Radboud University
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
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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
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 May 19, 2013