Clinical Trial: A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study.

Brief Summary: Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.

Detailed Summary:

Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.

This is a pilot double blind placebo controlled study.

A total of twenty patients (both males and females) will be recruited; ten will be randomly assigned to the placebo controlled arm and ten to the study medication arm.

Inclusion criteria:

  • IBS patients (both males and females) with positive diagnosis based on Rome II criteria [20]
  • age ≥ 18 years
  • Patients capable of conforming to the study protocol;
  • Patients who have given their free and informed consent

Exclusion criteria:

- Patients with ascertained Inflammatory Bowel Diseases (Crohn disease, Diverticular disease, Ulcerative colitis, Infectious colitis, Ischemic colitis, microscopic colitis); food intolerance/allergy; active malignancy of any type, or history of a malignancy; presence of major abdominal surgeries; ascertained hypersensitivity to the salicylates; positive faecal culture for bacterial, mycotic or parasitic pathogens; patients with history of clinically significant renal (creatinine ≥ 2.0 mg/dL or ≥177 μmol/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease; esophageal, gastric or duodenal ulcer within 30 days prior to randomization; patients with intended or ascertained pregnancy; lactation
Sponsor: SOFAR S.p.A.

Current Primary Outcome: The primary endpoint in the study was to assess the effect of mesalazine treatment on total number of mucosal immune cells in the colonic mucosa of patients with IBS. [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of mesalazine on: 1) mucosal immune cell subsets; 2) inflammatory mediator release from mucosal biopsies; 3) symptom relief, as detected by means of visual analogue scales. [ Time Frame: 8 weeks ]

Original Secondary Outcome: Same as current

Information By: SOFAR S.p.A.

Dates:
Date Received: October 15, 2008
Date Started: September 2004
Date Completion:
Last Updated: October 15, 2008
Last Verified: October 2008