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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOFAR S.p.A.
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; St. Orsola Hospital
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• IBS patients (both males and females) with positive diagnosis based on Rome II criteria

• 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)

• Patients with ascertained food intolerance/allergy

• Patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)

• Presence of major abdominal surgeries

• Ascertained hypersensitivity to the salicylates

• Positive faecal culture for bacterial, 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

• Patients who become unable to conform to protocol

• Patients who are continuously taking laxatives

• Patients in antibiotic therapy during the last month

• Patients in current therapy with corticosteroids

• Treatment with any investigational drug within the previous 30 days

• Treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety

• Recent history or suspicion of alcohol abuse or drug addiction

• Any severe pathology that can interfere with the treatment or the clinical tests of the trial

• Previous participation in this study