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Metabolites
Volume 13
Issue 2
10.3390/metabo13020182
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Study Protocol

The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms; Function and Composition of Gut Microbiota; and Metabolic, Inflammation, and Oxidative Stress Markers in Patients with Depression—A Study Protocol

by
Anna Skowrońska
1,
Oliwia Gawlik-Kotelnicka
1,*,
Aleksandra Margulska
2 and
Dominik Strzelecki
1
1
Department of Affective and Psychotic Disorders, Central Teaching Hospital, Medical University of Łódź, ul. Czechosłowacka 8/10, 92-216 Łódź, Poland
2
Department of Adolescent Psychiatry, Central Teaching Hospital, Medical University of Łódź, ul. Czechosłowacka 8/10, 92-216 Łódź, Poland
*
Author to whom correspondence should be addressed.
Metabolites 2023, 13(2), 182; https://doi.org/10.3390/metabo13020182
Submission received: 10 December 2022 / Revised: 11 January 2023 / Accepted: 20 January 2023 / Published: 25 January 2023
(This article belongs to the Special Issue The Microbiota–Gut–Brain Axis: Role of Metabolism)
Review Reports Versions Notes

Abstract

This article aims to present the theoretical basis, methodology, and design of a clinical trial we will conduct. The study will be prospective, randomized, placebo-controlled, and double-blind. Each intervention period will last 8 weeks and the trial will be conducted on 100 patients in total, who will be randomly divided into two groups consisting of 50 patients each. We plan to investigate the impact of Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on the depressive, anxiety, and stress levels in patients with depressive disorders with possible comorbid anxiety. In addition to assessing the influence of probiotics on the clinical condition, we also plan to study the clinical and biochemical parameters of metabolic syndrome, which often coexists with depression. Both depressive and metabolic issues may have part of their etiopathology in common, e.g., inflammation, oxidative stress, and dysbiosis. This is why we will additionally investigate the parameters related to gut microbiota, inflammatory, and oxidative statuses. Thus, the primary endpoint of the study will be the change in depression score measured with the Montgomery–Åsberg Depression Rating Scale. The secondary endpoints will include changes in anxiety and stress levels, as well as metabolic, inflammation, and oxidative stress parameters.
Keywords: microbiome; metabolism; depression; anxiety disorders microbiome; metabolism; depression; anxiety disorders

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MDPI and ACS Style

Skowrońska, A.; Gawlik-Kotelnicka, O.; Margulska, A.; Strzelecki, D. The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms; Function and Composition of Gut Microbiota; and Metabolic, Inflammation, and Oxidative Stress Markers in Patients with Depression—A Study Protocol. Metabolites 2023, 13, 182. https://doi.org/10.3390/metabo13020182

AMA Style

Skowrońska A, Gawlik-Kotelnicka O, Margulska A, Strzelecki D. The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms; Function and Composition of Gut Microbiota; and Metabolic, Inflammation, and Oxidative Stress Markers in Patients with Depression—A Study Protocol. Metabolites. 2023; 13(2):182. https://doi.org/10.3390/metabo13020182

Chicago/Turabian Style

Skowrońska, Anna, Oliwia Gawlik-Kotelnicka, Aleksandra Margulska, and Dominik Strzelecki. 2023. "The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms; Function and Composition of Gut Microbiota; and Metabolic, Inflammation, and Oxidative Stress Markers in Patients with Depression—A Study Protocol" Metabolites 13, no. 2: 182. https://doi.org/10.3390/metabo13020182

APA Style

Skowrońska, A., Gawlik-Kotelnicka, O., Margulska, A., & Strzelecki, D. (2023). The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms; Function and Composition of Gut Microbiota; and Metabolic, Inflammation, and Oxidative Stress Markers in Patients with Depression—A Study Protocol. Metabolites, 13(2), 182. https://doi.org/10.3390/metabo13020182

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