![]() Based on these criteria, we identified that we needed to enroll a minimum of n = 10 “responders” in placebo and spore-based probiotic groups ( n = 20 total) in order to achieve at least 80% statistical power. “Responder” subjects experienced a 30% reduction in serum endotoxin (effect size = 0.40) at 5-h post-prandial following a 30-d probiotic intervention (same probiotic used in the present study). From this data, we identified that only 2 of 6 subjects (“responders”) had a measurable dietary endotoxemia response ( i.e., at least a 5-fold increase from pre-meal values at 5-h post-prandial). ![]() The present study was completed following a completion of a preliminary proof of concept study in the laboratory (data not shown). Subjects provided their written and verbal consent to participate before being enrolled in the study. ![]() Our secondary purpose was to determine if other metabolic biomarkers and cytokines, known to change after consuming a high-fat meal, would also be modified by 30-d of spore-based probiotic supplementation.Īll the procedures described in the present study were reviewed and approved by the University of North Texas Institutional Review Board (IRB) for Human Subject’s Research. The study enrollment was unique in that we developed an additional level of screening to only enroll subjects who had dietary endotoxemia ( i.e., responders). The primary purpose of the present study was to determine if 30-d of spore-based probiotic supplementation reduced post-prandial endotoxemia and triglycerides. To our knowledge, the present study is the first attempt to clinically leverage the benefits of spore-based probiotics to improve health outcomes. According to the literature the biggest advantages of a “spore-based” probiotic is that it is compose of endosomes which are highly resistant to acidic pH, are stable at room temperature, and deliver a much greater quantity of high viability bacteria to the small intestine that traditional probiotic supplements. To address known issues with sufficient probiotic delivery, we utilized a “spore-based” probiotic in the present study. Given the direct link between nutrition, microbiota, GI permeability, and disease risk, our laboratory and others have speculated that these changes represent an appropriate treatment target for a probiotic intervention. The post-prandial time course varies for each biomarker, but generally the transient changes occur during the first five hours of the post-prandial period. Our laboratory and others have demonstrated that consumption of a single, high-fat, high-calorie meal was associated with an increase in serum endotoxin, triglycerides, metabolic biomarkers, inflammatory cytokines, endothelial microparticles, and monocyte adhesion molecules. Dietary endotoxemia transiently increases systemic inflammation, which chronically may increase one’s risk of a variety of diseases. Thus, it appears that two major limitations of the existing probiotic literature lie with an inability to identify “responder” subjects prior to enrollment and issues associated with viable probiotic delivery to the small intestine.ĭietary or metabolic endotoxemia occurs when one’s dietary consumption causes disruption in either GI permeability, the microbiota profile, or both. Recently it has been speculated gram positive, spore-forming probiotic strains may be a good alternative because the endospores that encapsulate the strains are highly resistant to stomach acid, potentially resulting in the delivery of more viable probiotics to the small intestine. Complicating oral probiotic supplementation efforts is the fact that few traditional probiotic supplements ( i.e., Lactobacillus and Bifidobacterium) delivery fully viable bacteria to the small intestine. We have speculated that if an individual doesn’t have a pre-existing GI abnormality then they would not be a “responder” to probiotic supplementation. Further complicating matters is that probiotic supplementation does not yield consistent results. The lay literature has generally identified a goal of improved “GI health”, but unfortunately this is so broadly defined that it is nearly impossible to identify a single research focus. ![]() Recent efforts have focused on the use of over-the-counter probiotics (typically Lactobacillus and Bifidobacterium) to address symptoms associated with GI abnormalities. ![]() These same dietary choices coupled with low physical activity are believed to be the primary causes underlying the current obesity epidemic. Incidence of gastrointestinal (GI) distress and permeability has increased in prominence in modern society due in large part to the excessive consumption of highly processed, calorie dense, commercially available foods. ![]()
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