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

Evaluation of the effectiveness of adding probiotic / prebiotic combination to the usual treatment on the severity of depressive symptoms and irritable bowel syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190404043159N5

Enrollment

Registered

2021-12-13

Start date

2021-12-22

Completion date

Unknown

Last updated

2022-01-11

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: Intervention group 1: For patients in this group, in addition to the usual treatment, the probiotic/prebiotic combination of familact 2 Plus (which contains eight bacterial strains and

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Sharbafchi

Esfahan University of Medical Sciences

sharbafchi@med.mui.ac.ir+98 31 3668 0042

Outcome results

None listed

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