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

Overview

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.

Full Title of Study: “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

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

Interventions

  • Drug: Sulindac (drug)
  • Drug: VSL#3 (probiotic)
  • Drug: Inulin (probiotic)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Collaborator
    • Dutch Cancer Society
  • Overall Official(s)
    • Fokko M Nagengast, PhD, Principal Investigator, Radboud University Medical Center
  • Overall Contact(s)
    • Pieter Friederich, MD, 00-31-24-3614760, P.Friederich@mdl.umcn.nl

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.