The aim of this study is to gather empirical evidence which will enable to evaluate the impact of probiotic supplementation on the severity of anxiety and depressive symptoms, function, and composition of gut microbiota, metabolic parameters, inflammation, and oxidative stress markers in patients with diagnosed depressive disorders. The designed study will be prospective, randomized, placebo-controlled, and double-blind. The intervention period will last 8 weeks for each patient. The study will be conducted on 100 patients in total, who will be randomly divided into two groups, consisting of 50 patients each. Patients included in Group I (PRO-D) will receive one capsule daily containing a probiotic mixture at a daily dose of 3×109 colony-forming units (CFU). The probiotic will be composed of two bacteria strains: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell, made of hydroxypropylmethylcellulose. Patients included in Group II (PLC-D) will receive daily the same capsule, containing only excipients: potato starch, maltodextrin, and the capsule shell. The color, smell, and taste of the placebo will not be different from those included in the probiotic capsule. Patients will be considered compliant if they consume \>= 80% of the supplements. The primary outcome measures will be the severity of depressive anxiety and stress symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) and the Depression, Anxiety, Stress Scale (DASS) with subscales scores, the quality of life level assessed with the WHOQOL-BREF instrument. The secondary outcomes measures will include: blood pressure (BP), body mass index (BMI) and waist circumference (WC) measures, fasting glucose (fGlc), HDL cholesterol (HDL-C), triglycerides (TG), white blood cells count (WBC), neutrofiles, serum levels of C-reactive protein (CRP), the level of faecal SCFAs, faecal microbiota α-diversity and the level of oxidative stress parameters (total antioxidant capacity (TAC) and malondialdehyde (MDA)) in the blood serum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
We plan to investigate the impact of the Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on clinical and biochemical parameters in the experimental group.
We plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group.
Central Teaching Hospital, Medical University of Lodz
Lodz, Poland
RECRUITINGMontgomery-Åsberg Depression Rating Scale (MADRS)
10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disturbances. The overall score ranges from 0 to 60 (most severe depression).
Time frame: 8 weeks
Depression, Anxiety, Stress Scale (DASS21)
21-item self-administered questionnaire, designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. These scores ranged from 0 ("did not apply to me at all") to 3 ("apply to me very much or most of the time").
Time frame: 8 weeks
The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.
Time frame: 8 weeks
Blood pressure (BP)
Routine measurements in a seated position after 5 minutes of rest.
Time frame: 8 weeks
Body mass index (BMI)
Defined as the body mass (kg) divided by the square of the body height (m). Major adult BMI classifications are underweight (under 18.5 kg/m2), normal weight (18.5 to 24.9), overweight (25 to 29.9), and obese (30 or more).
Time frame: 8 weeks
Waist circumference (WC)
Wrapping the tape measure around the widest part of stomach, across the navel.
Time frame: 8 weeks
White blood cells count (WBC)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
Neutrofiles count
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
Serum levels of C-reactive protein (CRP)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
The level of faecal short-chain fatty acids (SCFAs)
Each patient included in the study will be asked to collect a sample of feces twice in a specially designed double sealed bag, which will allow keeping anaerobic conditions.
Time frame: 8 weeks
Faecal microbiota α-diversity
Each patient included in the study will be asked to collect a sample of feces twice in a specially designed double sealed bag, which will allow keeping anaerobic conditions.
Time frame: 8 weeks
Total antioxidant capacity (TAC) in the blood serum
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
Malondialdehyde (MDA) level in the blood serum
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
Fasting glucose (fGlc)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
HDL cholesterol (HDL-C)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
Triglycerides (TG)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time frame: 8 weeks
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