A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome (NCT00774007) | Clinical Trial Compass
CompletedPhase 2/3
A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome
Italy20 participantsStarted 2004-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 inves…
What they're measuring
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.