The efficacy and safety of probiotics intervention in attenuating cardiac remodeling following myocardial infraction: Literature review and study protocol for a randomized, double-blinded, placebo controlled trial

Abstract

Introduction Structural and functional changes that occur post myocardial infraction (MI) lead to the syndrome of heart failure (HF). However, their pathogenesis is poorly understood. Recently, alteration of the intestinal microbiota (dysbiosis) has emerged as a new candidate that may be correlated with risk of HF development. We hypothesized that selective gut modulation by probiotic administration may improve metabolic dysfunction and attenuate cardiac remodeling (CR) in MI subjects. Methods /Design: This article is presented in two sections: First, we provided a review of recent findings related to gut microbiota and CR and their association with probiotic supplementation. Secondly, we will conduct a randomized double-blinded controlled clinical trial in 46 Iranian patients with MI after successful percutaneous coronary intervention (PCI). The participants (age: ≥ 30 years; ejection fraction (EF) greater than 30) will be selected by a simple random sampling method and will be assigned to 3 months of 1.6* 10 9 CFU probiotic (Lactobacillus rhamnosus), or placebo groups (maltodextrin). The primary outcome is development of CR. The secondary outcomes measures include gut microbiota profile, biochemical variables and the safety of the probiotics supplementation. Also, echocardiography will be measured at baseline and following treatment. The data will be compared within and between groups using appropriate statistical methods. Discussion The results of this trial will provide evidence about the efficacy and safety of gut microbiota manipulation by probiotics in post-MI cardiac remodeling prevention. Ethical issues Present study protocol was approved by the regional committee of ethics in international branch of Tabriz University of Medical sciences (TBZMED) as a thesis proposal for PhD degree in Nutrition Sciences ( IR.TBZMED.REC.1397.184 ). Trial registration The Clinical trial was registered in the Iranian Registry of Clinical Trials (IRCT20121028011288N15).

Dietary Inflammatory Index Is Related to Heart Failure Risk and Cardiac Function: A Case–Control Study in Heart Failure Patients

“…We obtained dietary intake by making use of a 138-item semi-quantitative FFQ involving of a list of a finite foods and beverages with standard serving sizes usually consumed by Iranians ( 26 , 27 ). Patients were requested to state how often they consumed each of the food listed by the number of times (every day, weekly, once a month, and annually).…”

Therapeutic and Improving Function of Lactobacilli in the Prevention and Treatment of Cardiovascular-Related Diseases: A Novel Perspective From Gut Microbiota

“…Tissue weight assessment and atrial natriuretic peptide gene expression in MI rats given L. rhamnosus showed a substantial attenuation of left ventricular hypertrophy (LVH), and various ultrasound indicators reflected the improvement of left ventricular function ( 186 ). A clinical study also proved the effectiveness and safety of Lactobacillus supplementation in preventing cardiac remodeling after MI ( 42 ). Supplementation of L. rhamnosus in patients with coronary artery disease had beneficial effects on depression, anxiety, and inflammatory biomarkers ( 44 , 45 ).…”

Interactive Effect of Probiotics Supplementation and Weight Loss Diet on Metabolic Syndrome Features in Patients With Coronary Artery Diseases: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

“…The trial was registered at the Iranian Registry of Clinical Trials (IRCT20121028011288N15), after approval of the study protocol by the Medical Ethics Committee of TBZMED (IR.TBZMED.REC.1397.184). 18 Informed consent was taken from all the study subjects. All the patients with CAD admitted to the participating hospitals were considered for possible enrollment into the study, and they were screened by an expert cardiologist for eligibility.…”