Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to severe irritable bowel syndrome in adults.
Phase 2
- Conditions
- Irritable bowel syndrome.Irritable bowel syndrome
- Registration Number
- IRCT138805012159N2
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
age 18-65 years, IBS diagnosis through ROME II criteria, moderate to severe symptoms through severity of symptom questionnaire Exclusion criteria : Diagnosis of any organic disease related to symptoms during the study, psychological disorders Taking any other psychotropic drugs at the beginning or during the trial or taking a MAO-inhibitor drugs during 2 weeks before entering to the trial, record of taking Fluoxetine for treatment of IBS in the past, Presence of any contraindications for taking Fluoxetine, low compliance, severe complications due to Fluoxetine, Pregnancy or breastfeeding at the beginning or during the trial
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of symptom. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: IBS-SSS questionnaire.;Quality of life. Timepoint: baseline, end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: IBS quality of life questionnaire (IBS-QOL).
- Secondary Outcome Measures
Name Time Method Depression. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: Hospital anxiety and Depression questionnaire.;Anxiety. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: Hospital anxiety and Depression questionnaire.