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.

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 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 (). The Clinical trial was registered in the Iranian Registry of Clinical Trials (IRCT20121028011288N15).