Use of SBI, an Oral Medical Food as an Option for Various Gastrointestinal Disorders

Abstract

Introduction: Oral medical foods have been used for decades for nutritional support, primarily in institutional settings. It is now possible to utilize prescription medical foods for gastrointestinal (GI) disorders in medical practice. Oral serum-derived bovine immunoglobulin/protein isolate (SBI) has been shown to reduce loose stools, improve stool consistency as well as other symptoms (i.e., abdominal pain, bloating, urgency) in patients with diarrhea predominant irritable bowel syndrome (IBS-D) syndrome and HIV-associated enteropathy. This current assessment followed 18 difficult to treat patients in outpatient medical practice setting using SBI as an addition to standard of care. The population consisted of 18 patients: 14 IBS (2 constipation predominant IBS (IBS-C), 7 IBS-D, 2 Mixed IBS (IBS-M), 3 IBS), 2 Crohn’s disease, 1 J-pouch, and 1 chronic ischemic bowel, and ranged in age from 22-92 years. SBI was added to their current care at a daily dose of either 5 or 10 g and followed for several weeks to determine if treatment helped to address and manage their symptoms. Primary symptoms included abdominal pain, diarrhea, bloating, distention and incontinence. Overall, 16 of the 18 patients showed improved symptoms while 2 patients discontinued therapy. One IBS patient was non-compliant during 8 weeks of therapy and 1 IBS-C patient showed improved bowel movements, but felt the therapy was ineffective and chose to discontinue after 11 weeks of therapy. Of the remaining 16 patients who remained on therapy, they reported an overall improvement in symptoms with improved stool consistency, decreased frequency as well as improvements in abdominal pain, bloating, distention, incontinence, nausea and some reports of improved appetites. Two patients reported a resolution or near resolution of symptoms. In most cases, therapeutic effects of SBI were seen within the first 4 weeks of therapy with continued improvements at subsequent visits. In some cases, the removal of other medications was made given patient response with SBI. GI disorders that result in severe chronic changes in motility can be difficult to treat and many patients fail on conventional drug therapies. The multifaceted mechanism of action and specificity of SBI may help to manage chronic motility problems and other symptoms in these difficult to treat patients. Evidence in animal models has shown that SBI can reduce intra-luminal bacterial products, bind with bacterial lipopolysaccharides, and enhance tight junctions between intestinal epithelial cells. Medical foods are a safe treatment option for patients with IBS and other gastrointestinal disorders. Disclosure - Bryon Petschow, PhD - employee of Entera Health, Inc.