1. Introduction
anxiety, metabolic complications, inflammation, metabolic syndrome, MetS, depression, Depression, depressiveness, depressive disorders
INFLAMMATION, RECRUITMENT, PATHOPHYSIOLOGY, SECONDARY, METABOLIC SYNDROME, DISEASES
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 The global incidence of depressive disorders and metabolic syndrome (MetS) is growing, and is responsible for significant morbidity and mortality [The role of gut microbiota function in the pathophysiology of civilization diseases has recently become a source of interest [Microbiota interventions, e.g., those based on diet changes or consumption of prebiotics, may reduce the risk of depression [Hence, there is a need to identify specific conditions, including features in the clinical population, that may support the curative action of probiotics. For example, there is limited but promising evidence with regard to the effectiveness of probiotics regarding the risk of depressiveness or anxiety in the perinatal period [It is known that the effects of probiotic supplementation are strongly strain-dependent, and it is widely believed that a mixture of collaborating microbes would be more beneficial than a single strain. Therefore, a combination of Based on the above rationale, a Pro-demet randomized controlled trial protocol was constructed [The primary aim of this pilot study was to assess eligibility rates. The secondary aims were to assess the recruitment and enrolment rates, and the capacity and resources to conduct all trial processes; examine potential participant retention and adherence among the allocation groups, and data completeness. Several tertiary aims are also discussed in the manuscript.Our hypothesis was that the recruitment rate would be around 15–20 subjects per month and that at least half of them would be eligible and would agree to enroll.This pilot study manuscript has been planned and prepared according to a checklist for pilot studies using the CONSORT statement [