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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319007

Enrollment

Registered

2006-04-27

Start date

2006-04-30

Completion date

2006-12-31

Last updated

2007-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyposis Coli

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.

Interventions

DRUGSulindac (drug)

DRUGVSL#3 (probiotic)

DRUGInulin (probiotic)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pouch mucosal proliferation index at 0, 1 and 2 months	—
Pouch mucosal apoptosis index at 0, 1 and 2 months	—

Secondary

Measure	Time frame
Faecal cytotoxicity at 0, 1 and 2 months	—
Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months	—
Faecal genotoxicity at 0, 1 and 2 months	—

Countries

Netherlands

Contacts

Primary ContactPieter Friederich, MD

P.Friederich@mdl.umcn.nl00-31-24-3614760

Backup ContactFokko M Nagengast, PhD

F.Nagengast@mdl.umcn.nl00-31-24-3614760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026