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

August 9, 2007 updated by: Radboud University Medical Center

Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6533DD
        • Recruiting
        • Radboud University Nijmegen Medical Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pieter P Friederich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pouch mucosal proliferation index at 0, 1 and 2 months
Pouch mucosal apoptosis index at 0, 1 and 2 months

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Fokko M Nagengast, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

August 10, 2007

Last Update Submitted That Met QC Criteria

August 9, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23266
  • KUN 2003-2911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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