Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Trial Sites
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Prevention | Active | 16 and over | Other | 23266 KUN 2003-2911, NCT00319007 |
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 Lead Organizations/Sponsors
Universitair Medisch Centrum St. Radboud - Nijmegen
Dutch Cancer Society| Fokko M Nagengast, PhD |  | Principal Investigator |
| Pieter Friederich, MD | | Ph: 00-31-24-3614760 |
| Email: P.Friederich@mdl.umcn.nl | ||
Trial Sites
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| Netherlands | |||
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| Nijmegen | |||
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| 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, MD | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00319007
Information obtained from ClinicalTrials.gov on January 15, 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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