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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)

About this trial

This is an interventional prevention trial for Adenomatous Polyposis Coli

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pieter Friederich, MD

Phone

00-31-24-3614760

P.Friederich@mdl.umcn.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Fokko M Nagengast, PhD

Phone

00-31-24-3614760

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

P.Friederich@mdl.umcn.nl

First Name & Middle Initial & Last Name & Degree

Fokko M Nagengast, PhD

Phone

00-31-24-3504066

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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