Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial

Phase 3

Conditions: Irritable Bowel Syndrome.
Irritable bowel syndrome

Registration Number: IRCT20151106024901N5

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

Patients with IBS-D according to ROME IV criteria (Loose and watery stool at at least 25% and hardy stool less than 25% of bowel movement)
Age over 18 years
Predominant symptom of diarrhea
Calprotectin levels above 50 feces
Normal colonoscopy during the last 5 years

Exclusion Criteria

Pregnancy and lactation and those who plan to become pregnant
History of major abdominal surgery other than appendectomy and cholecystectomy
A history of allergic disease such as asthma in yourself or a first-degree relative
Celiac disease
History of known psychological disease
Consumption of anti-inflammatory drugs (corticosteroids, NSAIDs), mast cell stabilizers and antibiotics in the last 3 months
History of inflammatory bowel disease or ulcerative colitisSensitivity to sulfur-containing compounds such as mesalazine
Consumption of lactulose and recent probiotics
Evidence of organic disease in colonoscopy
Normal stool calprotectin

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal pain. Timepoint: Before and 8 weeks after the intervention. Method of measurement: visual analog scale (0=no pain; 10= worst pain).;Bloating. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on a questionnaire.;Diarrhea. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on the prepared questionnaire, the number of diarrhea per day will be measured.;Consumption of mesalazine. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on a questionnaire.;Fecal calprotectin levels. Timepoint: Before and 8 weeks after the intervention. Method of measurement: ELISA method with laboratory kit (calprest).

Secondary Outcome Measures