Clinical trial NCT04756544: The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity
Official title: he Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Anxiety
Stress
Metabolic Syndrome
NAFLD
Keywords: depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum.

The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.


Eligibility criteria: Inclusion Criteria:

Depressive disorders diagnosed according to ICD Age between 18 and 70 years MADRS score \>=13 Antidepressant and antianxiety medications or psychotherapy not changed 3 weeks prior to the beginning of the study DMS study groups: MetS diagnosed according to International Diabetes Federation (IDF)

Exclusion Criteria:

Pregnancy; An infection 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, severe kidney failure or unstable thyroid dysfunction in the previous 4 weeks; Psychiatric comorbidities (except for specific personality disorder, additional specific anxiety disorder and caffeine or nicotine addiction); Regular treatment (more than 3 days a week) with proton-pump inhibitors (PPIs), metformin, laxatives, systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) in the previous 4 weeks; Following a specific diet or a significant change in dietary pattern in the previous 4 weeks; Significant change in daily physical activity or an extreme sport 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; A major neurological disorder or any medical disability that may interfere with a subject's ability to complete study procedures; High risk of suicide according to Tool of Assessment of Suicide Risk (TASR); Is participating in, or has recently participated in, another research study involving an intervention which 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; D study groups: MetS diagnosed according to International Diabetes Federation (IDF).

Primary outcomes:
measure: depressive symptoms
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Oliwia Gawlik-Kotelnicka
Study officials:
References:
citation: Gawlik-Kotelnicka O, Skowronska A, Margulska A, Czarnecka-Chrebelska KH, Loniewski I, Skonieczna-Zydecka K, Strzelecki D. The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation, and Oxidative Stress Parameters and Fecal Microbiota in Patients with Depression Depending on Metabolic Syndrome Comorbidity-PRO-DEMET Randomized Study Protocol. J Clin Med. 2021 Mar 24;10(7):1342. doi: 10.3390/jcm10071342.