Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to severe irritable bowel syndrome in adults.

Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to sever irritable bowel syndrome in adults.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138805012159N2

Enrollment

180

Registered

2010-05-29

Start date

2010-06-22

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

Interventions

Intervention 1: Fluoxetine 20 milligram, capsule, daily plus placebo capsule, oral, daily for 12 weeks. Intervention 2: 2 placebo capsules, oral, daily for 12 weeks. Intervention 3: Fluoxetine, 40 mil

Treatment - Drugs

Placebo

Fluoxetine 20 milligram, capsule, daily plus placebo capsule, oral, daily for 12 weeks

2 placebo capsules, oral, daily for 12 weeks

Fluoxetine, 40 milligram, 20 miligram capsules twice daily, oral, for 12 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactForugh Ghaedi

Isfahan University of Medical Sciences

f_ghaedi@edc.mui.ac.ir+98 31 1668 5149

Outcome results

None listed

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