Case Series Investigating the Clinical Practice Experience of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in the Clinical Management of Patients with Inflammatory Bowel Disease

Background: Serum-derived bovine immunoglobulin/protein isolate (SBI), a specially formulated oral protein source of >50% IgG and ~60% total immunoglobulins, has a multifaceted mechanism of action binding microbial components, maintaining gastrointestinal immune balance, managing gut barrier function and improving nutrient utilization. IBD animal models and a human refractory case study demonstrated that SBI can attenuate both inflammatory biomarkers and histological parameters in the bowel. Additionally, SBI is intended for the clinical dietary management of intestinal disorders due to limited/impaired capacity to ingest, digest, absorb or metabolize certain nutrients/foodstuffs or clinical dietary management of chronic loose and frequent stools. Given the known efficacy of SBI in gastrointestinal disorders and effects demonstrated in IBD animal models, SBI may help in the nutritional management of Inflammatory Bowel Disease (IBD) patients. Methods: In a clinical practice setting, we retrospectively evaluated seven ulcerative colitis (UC) and Crohn’s disease (CD) patients who incorporated SBI into their therapeutic regimens. All patients previously failed to adequately respond to conventional drug therapies. Their SBI response was assessed to determine its effect on further management in IBD patients. Results: The addition of SBI for nutritional management resulted in improved IBD symptoms including chronic loose and frequent stools. The UC patients reported resolution of symptoms such as rectal bleeding, urgency, and/or nocturnal incontinence. The CD patients reported weight improvements, other therapy reductions, and/or decrease ileostomy output and creatinine levels. Conclusion: Although this was a retrospective assessment of a small case series, the evidence suggests that SBI provided further management of IBD patients who were not fully controlled on traditional therapies by providing for distinctive nutritional requirements in these patients. Further study is warranted to evaluate this option as part of