The main target of the study is to determine and compare the effect of 20 and 40 milligrams Fluoxetine on symptoms and quality of life of patients with moderate to severe irritable bowel syndrome. 180 Patients with moderate to severe irritable bowel syndrome who refer to Poursinay Hakim clinic of Isfahan will be recruited if meet the eligibility criteria. The patients will be randomly assigned into one of the following groups to receive 20 mg Fluoxetine daily, 40 mg Fluoxetine daily, or placebo for 12 weeks. The severity of symptoms, quality of life, anxiety, and depression will be measured at the baseline and 4th and 12th week after the intervention. Symptoms will also be registered daily. The follow-up period will be 6 month and the outcomes will also be measured every 3 months during this period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805012159N2
Registration date:2010-05-29, 1389/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Forugh Ghaedi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 1467 9730
Email address
f_ghaedi@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to sever irritable bowel syndrome in adults.
Public title
Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to severe irritable bowel syndrome in adults.
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan
Street address
Isfahan University of Medical Sciences - Azadi square - Isfahan
City
Isfahan
Postal code
Approval date
2010-04-25, 1389/02/05
Ethics committee reference number
288243
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
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
2
Description
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 outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
Fluoxetine 20 milligram, capsule, daily plus placebo capsule, oral, daily for 12 weeks