Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

Adenomatous Polyposis Coli Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00319007
• Other study ID #: 23266
• Secondary ID: KUN 2003-2911
• Status: Recruiting
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: August 9, 2007
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: August 2007
• Source: Radboud University
• Contact: Pieter Friederich, MD
• Phone: 00-31-24-3614760
• Email: P.Friederich[@]mdl.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli

Intervention

Drug:
• Sulindac (drug)

• VSL#3 (probiotic)

• Inulin (probiotic)

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pouch mucosal proliferation index at 0, 1 and 2 months
Primary	Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary	Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
Secondary	Faecal genotoxicity at 0, 1 and 2 months
Secondary	Faecal cytotoxicity at 0, 1 and 2 months