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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151106024901N5
Enrollment
90
Registered
2021-08-24
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: 500 mg mesalazine tablets 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician. Intervention 2: Control group: received

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Mehdi Rasoolimanesh

Tabriz University of Medical Sciences

m_rasulimanesh@kaums.ac.ir+98 31 5554 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026