Serum-Derived Bovine Immunoglobulin/Protein Isolate for the Management of Diarrhea Associated with Chronic Pancreatitis and Pancreatic Insufficiency: A Novel Approach

Abstract

Chronic pancreatitis (CP) is a debilitating disorder that ultimately leads to pancreatic insufficiency (PI) and its sequelae. Patients with CP often experience abdominal pain, bloating, nausea, vomiting, weight loss, and steatorrhea. The dearth of pancreatic enzyme secretion in these patients leads to maldigestion, excess fat in the stool, and compromised nutritional status. A typical treatment for management of CP is pancreatic digestive enzyme therapy with pancrelipase, but it is usually ineffective in controlling pain and clinical symptoms, with potential risk of intestinal strictures. Serum-derived bovine immunoglobulin/protein isolate (SBI) is a prescription medical food that has been shown to manage chronic loose and frequent stools in patients with IBS-D, IBD, and HIV enteropathy. SBI has a multifaceted mode of action that through binding of microbial components, results in a downstream reduction in inflammatory markers and up-regulation of tight junction proteins, thus increasing barrier function. This results in improved nutrient utilization, as reported in non-clinical and clinical studies. For this reason, SBI was added to the therapy regimen of a CP/PI patient. The patient is a 73 year old female diagnosed with idiopathic CP and PI in 2012. She has a history of papillary stenosis diagnosed by ERCP with sphincterotomy. She also had chronic pancreatic steatorrhea that was managed with 5-6 doses of pancrelipase per day (at meals and snacks). This patient developed persistent bloating, distension, abdominal pain, and constipation, secondary to pancrelipase therapy. SBI 5g BID was added to her therapy regimen. Upon follow-up 7 weeks later, the patient reported improved discomfort, bloating and regularity of bowel movements to 1 every 2-3 days. The dosing of pacrealipase therapy was reduced due to this favorable response to SBI. She continues on SBI and is doing remarkably well in managing her condition, including her steatorrhea. Three other patients with CP/PI have also responded well to SBI therapy. For this patient, SBI proved to be a novel, safe option for the management of gastrointestinal issues associated with CP/PI. The ability of SBI to return the gut to homeostasis, restore barrier function, and thus allow for the proper absorption of nutrients from the diet may be the reason for its efficacy in this patient. A larger, well-controlled study in CP/PI patients is recommended.