Use of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) for the Management of DMARD-Induced Chronic Loose and Frequent Stools

Abstract

Serum-derived bovine immunoglobulin/protein isolate (SBI) is a prescription medical food intended for the dietary management of gastrointestinal disorders that present with chronic loose and frequent stools, namely IBS-D, IBD, and HIV enteropathy. As a medical food, SBI provides distinctive, specially formulated proteins in the form of immunoglobulins not attainable in the normal diet that bind microbial components. This results in a downstream reduction in inflammatory markers and up-regulation of tight junction proteins, thus decreasing permeability and increasing barrier function. These actions assist in managing underlying components associated with gastrointestinal conditions. Furthermore, SBI has been well-tolerated in fragile populations and has no contraindications with other medications. Due to its mode of actions, safety, and supporting clinical reports, SBI was used for the management of intractable diarrhea in an elderly female suffering from a variety of co-morbid conditions. Her response was retrospectively collected. This patient is a 61 year old African American female with a past medical history of systemic lupus erythematosus (SLE), type II diabetes, COPD, and depression. In addition to standard therapeutics to treat her co-morbid conditions, she had been given methotrexate, a disease-modifying antirheumatic drug (DMARD) to treat her SLE. However, this patient developed diarrhea due to the anti-folate drug and discontinued therapy. She was subsequently given leflunomide, another DMARD, but again discontinued after 2 weeks due to worsening of stool frequency and consistency which persisted even after she stopped the drug. Diagnostic colonoscopy results were negative for microscopic colitis and stool tests were negative for infectious agents, including C. difficile. At this time, SBI 5 g BID was initiated. Within 1 month, this patient reported management of stool frequency and consistency and continues on therapy. This patient, who developed persistent, chronic loose and frequent stools induced by methotrexate treatment, was able to manage her condition upon administration of SBI. This case highlights the applicability of this medical food for the management of chronic loose and frequent stools in patients who may have DMARD-induced diarrhea.