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Mesalamine effects on mucosal immune biomarkers in irritable bowel syndrome with diarrhea-predominant symptoms

Mesalamine effects on mucosal immune biomarkers in irritable bowel syndrome with diarrhea-predominant symptoms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012072910230N2
Enrollment
58
Registered
2012-12-17
Start date
2011-03-21
Completion date
Unknown
Last updated
2018-02-22

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 with diarrhoea

Interventions

placebo 3 times daily
Intervention 1: Mesalamine 800 mg three times a day for 2 months. Intervention 2: placebo 3 times daily. Intervention 3: Colonoscopy and biopsy at baseline and end of treatment.
Treatment - Drugs
Diagnosis
Mesalamine 800 mg three times a day for 2 months
Colonoscopy and biopsy at baseline and end of treatment

Sponsors

Digestive and Liver Disease Research Center, Shariati Hospital
Lead Sponsor
Rossen Darman company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Consent to participate in the study and signing the consent form; 2 - being at the age of 18 years and older. Exclusion criteria: 1 - Pregnancy or breast feeding; 2 - not using appropriate contraceptive methods; 3 - the use of NSAIDs; 4 - Use of corticosteroids, antibiotics, mast cell stabilizing drugs; 5- Large abdominal surgery; 6 - Celiac disease (positive Anti TTG and Anti Endomysial Ab); 7 - specific allergic diseases like asthma (positive family and personal history and positive Anti IGE); 8 - organic or psychological disorders characterized by history and specific laboratory tests; 9 - lack of cooperation in implementation of the Study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mucosal biomarkers. Timepoint: Before the study and at the end of study. Method of measurement: Sample Pathology.;Symptoms (diarrhea - abdominal pain - bloating - urgency - the number of bowel movements per day). Timepoint: Baseline, during and at the end of intervention. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Number of mast cell. Timepoint: Beginning and end of the intervention. Method of measurement: Sample pathology.;IHC CD117. Timepoint: Beginning and end of the intervention. Method of measurement: Sample pathology.;Gastrointestinal side effects (diarrhea - bloating - constipation). Timepoint: Initially, during and end of treatment. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Homayon Vahedi

Research Center for Gastroenterology and Liver

vahedi@ams.ac.ir+98 21 84901

Outcome results

None listed

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