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

Gawlik-Kotelnicka, Oliwia; Skowrońska, Anna; Margulska, Aleksandra; Czarnecka-Chrebelska, Karolina H.; Łoniewski, Igor; Skonieczna-Żydecka, Karolina; Strzelecki, Dominik

doi:10.3390/jcm10071342

Cited by 7 publications

(13 citation statements)

References 96 publications

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“…Moreover, recent study results suggested that Bifidobacterium species (spp.) positively correlated with both improved insulin resistance and obesity, and this might be associated with metabolic syndrome [ 59 , 60 ].…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2023

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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.

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Section: Resultsmentioning

confidence: 99%

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

et al. 2023

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“…Adult patients (≥18 years) with depressive disorders (as defined by 11th International Classification of Diseases [ 62 ]) were randomly assigned (1:1) into groups via computer-generated blocked lists stratified by the presence of MetS. Each participant received 60 days of treatment with probiotics ( Lactobacillus helveticus Rosell ® -52 and Bifidobacterium longum Rosell ® -175) or placebo consumed once daily [ 59 ]. Unblinding was permissible only if any serious adverse events occurred during the trial; however, it was not necessary.…”

Section: Methodsmentioning

confidence: 99%

“…Based on the above rationale, a Pro-demet randomized controlled trial protocol was constructed [ 59 ]. However, to ensure that the trial was feasible and to determine possible recruitment, eligibility and retention rates, an internal feasibility and pilot study was performed with an identical design to a Pro-demet full RCT.…”

Section: Introductionmentioning

confidence: 99%

PRO-DEMET Randomized Controlled Trial on Probiotics in Depression—Pilot Study Results

et al. 2023

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There is a pressing need to identify new treatment options for depression and its comorbidities. Depression often coexists with metabolic complications, and the two may share a pathophysiological overlap, including inflammation and microbiota changes. Microbiota interventions (e.g., probiotics) may represent a safe and easy-to-use treatment option as an adjunctive therapy in patients only partially responsive to pharmacologic treatment. (1) Objective: The paper presents the results of a feasibility and pilot study. The study is an internal part of a randomized controlled trail (RCT) of the effect of probiotic supplementation on psychometric, anthropometric, metabolic, and inflammatory parameters in adult patients with depressive disorders depending on the presence of metabolic syndrome. (2) Methods: The trial has a four-arm, parallel-group, prospective, randomized, double-blind, controlled design. Sixty participants received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 over 60 days. The feasibility of the study design was assessed, as well as the rates of recruitment, eligibility, consent, and study completion. The following were assessed: depressive, anxiety and stress symptoms, quality of life, blood pressure, body mass index and waist circumference, complete blood count with differential, serum levels of C-reactive protein, high-density lipoprotein cholesterol, triglycerides, fasting glucose, some secondary markers of inflammation and metabolic health, as well as noninvasive biomarkers of liver fibrosis (APRI and FIB-4). (3) Results: The study was found to be generally feasible. The eligibility rate was 52% of recruited participants with 80% completing the study protocol. No differences in sociodemographic or anthropometric factors or basic laboratory findings were found between the placebo and probiotic group at the start of the intervention period. Importantly, the proportion of recruited participants fulfilling the criteria of metabolic syndrome was too low. (4) Conclusions: Whilst the whole study protocol was feasible, some different timepoint procedures require modification. The major weakness of the recruitment methods was that the percentage of metabolic arms participants was insufficient. Overall, the full RCT design on probiotics in depression with vs. without metabolic syndrome was shown to be feasible with little modification.

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“…Recently, an open-label pilot study has been published that adds evidence to the antidepres-sant potential of this probiotic formulation [157]. Additionally, a RCT protocol of a study assessing antidepressant properties of the formulation in the context of MetS comorbidity has been published [158].…”

Section: Practical Applicationsmentioning

confidence: 99%

“…Proposed features of a new randomized clinical trial protocol of probiotics efficacy in depressive patients with metabolic abnormalities are summarized in Table 4. Based on the above, we have just registered a randomized clinical trial on the influence of probiotic supplementation on depressive symptoms, inflammation, oxidative stress and fecal microbiota in depressed patients depending on MetS comorbidity (ClinicalTrials.gov identifier: NCT04756544) [158].…”

Section: Practical Applicationsmentioning

confidence: 99%

Probiotics as a Treatment for “Metabolic Depression”? A Rationale for Future Studies

Gawlik-Kotelnicka

Strzelecki

2021

Pharmaceuticals

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Depression and metabolic diseases often coexist, having several features in common, e.g., chronic low-grade inflammation and intestinal dysbiosis. Different microbiota interventions have been proposed to be used as a treatment for these disorders. In the paper, we review the efficacy of probiotics in depressive disorders, obesity, metabolic syndrome and its liver equivalent based on the published experimental studies, clinical trials and meta-analyses. Probiotics seem to be effective in reducing depressive symptoms when administered in addition to antidepressants. Additionally, probiotics intake may ameliorate some of the clinical components of metabolic diseases. However, standardized methodology regarding probiotics use in clinical trials has not been established yet. In this narrative review, we discuss current knowledge on the recently used methodology with its strengths and limitations and propose criteria that may be implemented to create a new study of the effectiveness of probiotics in depressive disorders comorbid with metabolic abnormalities. We put across our choice on type of study population, probiotics genus, strains, dosages and formulations, intervention period, as well as primary and secondary outcome measures.

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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

Cited by 7 publications

References 96 publications

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

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

PRO-DEMET Randomized Controlled Trial on Probiotics in Depression—Pilot Study Results

Probiotics as a Treatment for “Metabolic Depression”? A Rationale for Future Studies

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