Serum-derived Bovine Immunoglobulin Isolate: A New Medical Food for the Clinical Dietary Management of Enteropathy

Abstract

Purpose: The intestinal epithelial barrier is critical in maintaining gut homeostasis. The loss of structural and functional integrity of the intestinal epithelial barrier increases permeability, which can allow greater antigenic penetration and subsequent activation of mucosal immune responses. The related inflammatory responses can contribute to several gastrointestinal (GI) disorders or enteropathies. The clinical manifestations vary among enteropathies, though abdominal pain or discomfort, bloating, flatulence, and altered bowel habits are common. The complex interactions between immune and nervous systems with the gut require a multifactorial, pathophysiological approach rather than targeting a single receptor/effector pathway. Methods: A number of studies suggest a potential role for serum-derived bovine immunoglobulin/protein isolate (SBI) to provide distinct nutrition in enteropathies, which decrease absorption and utilization of specific nutrients, alongside traditional medications that target specific aspects of the disease. SBI is a prescription medical food, specially formulated to be consumed orally or enterally under the medical supervision for the dietary management of enteropathy. It is affirmed as generally recognized as safe with no FDA objections. SBI has been shown in various nonclinical and clinical studies to have multiple mechanisms of action. These include: neutralizes bacterial endotoxins, balances intestinal microbiota, maintains integrity of the tight junctions, reduces cellular and soluble markers of immune activation, increases anti-inflammatory markers, and improves intestinal barrier dysfunction affected by inflammation. Results: Non-clinical trials have confirmed that plasma proteins containing immunoglobulins affects cellular immune activation, resulting in improved intestinal mucosal barrier function, reduced inflammation and diarrhea, as well as improved dietary protein utilization. In a HIV clinical study, SBI has been reported to decrease loose or watery bowel movements and increase absorptive function. Early studies in patients with IBS-D, malnutrition, or HIV enteropathy have noted improvements in nutrient retention and GI symptoms. Conclusion: The nutritional therapeutic approach aimed at restoring the mucosal membrane homeostasis and inhibiting intestinal immune activation through multiple mechanisms may be beneficial in GI disorders. Non-clinical and clinical studies demonstrate that nutritional management with SBI facilitates the restoration of the intestinal epithelial barrier and immune activation, thereby managing GI symptoms and improving nutritional status. SBI may prove beneficial in the nutritional management of diseases associated with intestinal inflammation.