The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms, as Well as the Function and Composition of Gut Microbiota, Metabolic, Inflammation, and Oxidative Stress Markers in Patients With Depression
Depression, Anxiety
About this trial
This is an interventional treatment trial for Depression focused on measuring probiotics, depression, anxiety, microbiome, metabolism
Eligibility Criteria
Inclusion Criteria: Depressive disorders diagnosed according to ICD-11, Age between 18 - 70 years, MADRS score >=13, Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit. Exclusion Criteria: Pregnancy, An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks, Supplementation with pro- or prebiotics in the previous 4 weeks, Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks, body mass index (BMI)> 35, glomerular filtration rate (GFR)< 30 ml/min/1,72 m2, unstable thyroid dysfunction (TSH < 0,27 or > 4,2 μIU/ml) in the previous 4 weeks, Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction), Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks, Significant change in dietary pattern in the previous 4 weeks, Significant change in daily physical activity or extreme sports activity in the previous 4 weeks, Significant change in dietary supplementation in the previous 4 weeks, Significant change in smoking pattern in the previous 4 weeks, High risk of suicide, Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study, Any other condition or situation which, in the view of investigators, would affect the compliance or safety of the individual taking part. Reasons for the participant to be discontinued from the study: Withdrawal of informed consent, An infection/vaccination and/or treatment with antibiotics during the trial, Consuming any other than studied probiotics during the trial, Lack of compliance with the probiotic supplementation, Any change in the drug regimen during the study, Exclusion criteria found after enrolment, Any serious adverse event during the trial.
Sites / Locations
- Central Teaching Hospital, Medical University of LodzRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group I "PRO-D"
Group II "PLC-D"
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.