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Article

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

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Department of Affective and Psychotic Disorders, Medical University of Lodz, 92-216 Lodz, Poland
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Admission Department, Central Teaching Hospital of Medical University of Lodz, 92-216 Lodz, Poland
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Department of Biomedicine and Genetics, Medical University of Lodz, 92-213 Lodz, Poland
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Department of Biochemical Sciences, Pomeranian Medical University in Szczecin, 71-460 Szczecin, Poland
*
Author to whom correspondence should be addressed.
Academic Editor: Sharmila Fagoonee
J. Clin. Med. 2021, 10(7), 1342; https://doi.org/10.3390/jcm10071342
Received: 25 February 2021 / Revised: 17 March 2021 / Accepted: 20 March 2021 / Published: 24 March 2021
There is a huge need to search for new treatment options and potential biomarkers of therapeutic response to antidepressant treatment. Depression and metabolic syndrome often coexist, while a pathophysiological overlap, including microbiota changes, may play a role. The paper presents a study protocol that aims to assess the effect of probiotic supplementation on symptoms of depression, anxiety and stress, metabolic parameters, inflammatory and oxidative stress markers, as well as fecal microbiota in adult patients with depressive disorders depending on the co-occurrence of metabolic syndrome. 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 (ClinicalTrials.gov identifier: NCT04756544). 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, high-density lipoprotein (HDL) cholesterol, triglycerides, fasting glucose, fecal microbiota composition and the level of some fecal microbiota metabolites, as well as serum inflammatory markers and oxidative stress parameters. The proposed trial may establish a safe and easy-to-use adjunctive treatment option in a subpopulation of depressive patients only partially responsive to pharmacologic therapy. View Full-Text
Keywords: depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress
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MDPI and ACS Style

Gawlik-Kotelnicka, O.; Skowrońska, A.; Margulska, A.; Czarnecka-Chrebelska, K.H.; Łoniewski, I.; Skonieczna-Żydecka, 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, 10, 1342. https://doi.org/10.3390/jcm10071342

AMA Style

Gawlik-Kotelnicka O, Skowrońska A, Margulska A, Czarnecka-Chrebelska KH, Łoniewski I, Skonieczna-Żydecka 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. Journal of Clinical Medicine. 2021; 10(7):1342. https://doi.org/10.3390/jcm10071342

Chicago/Turabian Style

Gawlik-Kotelnicka, Oliwia, Anna Skowrońska, Aleksandra Margulska, Karolina H. Czarnecka-Chrebelska, Igor Łoniewski, Karolina Skonieczna-Żydecka, and Dominik Strzelecki. 2021. "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" Journal of Clinical Medicine 10, no. 7: 1342. https://doi.org/10.3390/jcm10071342

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