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

NCT ID: NCT00319007

Last Updated: 2007-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenomatous Polyposis Coli

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Sulindac (drug)

Intervention Type DRUG

VSL#3 (probiotic)

Intervention Type DRUG

Inulin (probiotic)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Fokko M Nagengast, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Pieter Friederich, MD

Role: CONTACT

[email protected]
00-31-24-3614760

Fokko M Nagengast, PhD

Role: CONTACT

[email protected]
00-31-24-3614760

Facility Contacts

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Pieter Friederich, MD

Role: primary

[email protected]
00-31-24-3614760

Fokko M Nagengast, PhD

Role: backup

[email protected]
00-31-24-3504066

Other Identifiers

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KUN 2003-2911

Identifier Type: -

Identifier Source: secondary_id

23266

Identifier Type: -

Identifier Source: org_study_id