This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
St. Orsola Hospital
Information provided by:
SOFAR S.p.A. Identifier:
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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 Intervention Phase
Irritable Bowel Syndrome Drug: mesalazine Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by SOFAR S.p.A.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 20
Study Start Date: September 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: placebo
Active Comparator: Mesalazine
mesalazine 800 mg t.i.d.
Drug: mesalazine

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: October 15, 2008
Last Updated: October 15, 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 processed this record on September 19, 2017