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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774007
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : October 16, 2008
St. Orsola Hospital
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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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: mesalazine Drug: placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study.
Study Start Date : September 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: placebo
Active Comparator: Mesalazine
mesalazine 800 mg t.i.d.
Drug: mesalazine

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774007

Department of Internal Medicine & Gastroenterology
Bologna, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital
Principal Investigator: Giovanni Barbara, MD University of Bologna
Study Chair: Roberto Corinaldesi, MD University of Bologna

Responsible Party: Dr. Giovanni Barbara, Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, ITALY Identifier: NCT00774007     History of Changes
Other Study ID Numbers: IBS-01/03
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by SOFAR S.p.A.:
Irritable bowel syndrome, abdominal pain, abdominal bloating, immune cells, mast cells

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents