Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Primary Purpose
Adenomatous Polyposis Coli
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Sulindac (drug)
VSL#3 (probiotic)
Inulin (probiotic)
Sponsored by
About this trial
This is an interventional prevention trial for Adenomatous Polyposis Coli
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
Sites / Locations
- Radboud University Nijmegen Medical CentreRecruiting
Outcomes
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
Full Information
NCT ID
NCT00319007
First Posted
April 27, 2006
Last Updated
August 9, 2007
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT00319007
Brief Title
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyposis Coli
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sulindac (drug)
Intervention Type
Drug
Intervention Name(s)
VSL#3 (probiotic)
Intervention Type
Drug
Intervention Name(s)
Inulin (probiotic)
Primary Outcome Measure Information:
Title
Pouch mucosal proliferation index at 0, 1 and 2 months
Title
Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary Outcome Measure Information:
Title
Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
Title
Faecal genotoxicity at 0, 1 and 2 months
Title
Faecal cytotoxicity at 0, 1 and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Friederich, MD
Phone
00-31-24-3614760
Email
P.Friederich@mdl.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Fokko M Nagengast, PhD
Phone
00-31-24-3614760
Email
F.Nagengast@mdl.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fokko M Nagengast, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6533DD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Friederich, MD
Phone
00-31-24-3614760
Email
P.Friederich@mdl.umcn.nl
First Name & Middle Initial & Last Name & Degree
Fokko M Nagengast, PhD
Phone
00-31-24-3504066
Email
F.Nagengast@mdl.umcn.nl
First Name & Middle Initial & Last Name & Degree
Pieter P Friederich, MD
12. IPD Sharing Statement
Learn more about this trial
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
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