Overview

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