MedPath

Evaluation of the effectiveness of probiotic/prebiotic on the severity of depressive symptoms and irritable bowel syndrome

Phase 3
Recruiting
Conditions
Irritable bowel syndrome.
Irritable bowel syndrome
Registration Number
IRCT20190404043159N5
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
48
Inclusion Criteria

Age 18 to 65 years
Diagnosis of moderate to severe IBS based on ROME III criteria
Have a minimum literacy
Absence of Depressive Disorders, Bipolar Disorders or Psychotic Disorders Based on DSM-V Diagnostic Criteria by Psychiatrist and Psychiatric Assistant
No suicidal plans or thoughts at the time of enrollment
Do not take antidepressants and anti-anxiety drugs at the time of enrollment until 2 weeks before
No pregnancy or breastfeeding
No history of any bowel surgery
Do not use drugs since the onset of symptoms
Satisfaction to participate in the study

Exclusion Criteria

Diagnosis of any organic disease during the study
Lack of cooperation in taking medications regularly
Causes any side effects, including allergic and gastrointestinal side effects

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Symptoms of Irritable Bowel Syndrome. Timepoint: Before intervention, 6 and 12 weeks after intervention. Method of measurement: Questionnaire the irritable bowel severity scoring system (IBSSS).
Secondary Outcome Measures
NameTimeMethod
Depression. Timepoint: Before intervention, 6 and 12 weeks after intervention. Method of measurement: Questionnaire of Depression, Anxiety and Stress Scale (DASS).;Anxiety. Timepoint: Before intervention, 6 and 12 weeks after intervention. Method of measurement: Questionnaire of Depression, Anxiety and Stress Scale (DASS).;Stress. Timepoint: Before intervention, 6 and 12 weeks after intervention. Method of measurement: Questionnaire of Depression, Anxiety and Stress Scale (DASS).
© Copyright 2025. All Rights Reserved by MedPath