Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 27, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 10, 2007
August 1, 2007
April 27, 2006
August 9, 2007
Conditions
Outcome Measures
Primary Outcomes (2)
Pouch mucosal proliferation index at 0, 1 and 2 months
Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Clinically or genetically proven familial adenomatous polyposis
- Restorative proctocolectomy with ileal pouch anal anastomosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Dutch Cancer Societycollaborator
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, 6533DD, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fokko M Nagengast, PhD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2006
First Posted
April 27, 2006
Study Start
April 1, 2006
Study Completion
December 1, 2006
Last Updated
August 10, 2007
Record last verified: 2007-08