Effects of probiotic and prebiotic supplements in patients with major depressive disorder

Not Applicable

• Conditions: Condition 1: major depressive disoreders. Condition 2: Mild depression. Condition 3: Moderate depression.; Depressive episode; Mild depressive episode; Moderate depressive episode

• Registration Number: IRCT2015092924271N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

range for ages 18 to 50 years; mild to moderate melancholic type of major depression; intake of the following anti-depressant drugs: sertraline, fluoxetine and citalopram.
Exclusion criteria: history of renal, hepatic, cardiovascular, respiratory diseases or food allergy; pregnancy and lactation; regular intake of probiotic less than 2 months before the beginning of the study; intake of the antioxidant or omega 3 supplements 6 weeks before the beginning of the study; alcohol intake; smoking cigarette (more than 5 Sticks during last 6 month) or tobacco (pipe and hookah at least one time during last month); any addiction to opiates; history of heart attack or stroke; following of specific diet; participation in another study during last two months; intake of drugs other than antidepressant drugs; allergy to the components of study supplements; any significant change in the diet and life style; any change in the drug regiment; inflammatory disease which last more than one week during the study; intake of antibiotics during the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum free leptin. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with sensetive ELISA.;TNF-a. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;IL_1ß. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;IL-6. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;Tryptophane. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with HPLC.;Cortisol. Timepoint: before and after the intervention. Method of measurement: mass specterometry will be used for measuring urinary level of cortisol.;Depression. Timepoint: before and after the intervention. Method of measurement: Beck questionaire.;Appetite score. Timepoint: before and after the intervention. Method of measurement: visual analogue scale questionaire.

Secondary Outcome Measures

Name	Time	Method
Weight. Timepoint: before and after the intervention. Method of measurement: Weighing scale.;Energy intake. Timepoint: before and after the intervention. Method of measurement: 24-hour recall.;Physical activity. Timepoint: before and after the intervention. Method of measurement: IPAQ questionnaire.;Height. Timepoint: before and after the intervention. Method of measurement: height scale.