Serum-Derived Bovine Immunoglobulin/Protein Isolate Therapy for Patients with Refractory Irritable Bowel Syndrome

Abstract

Background: A small double-blind study showed benefits of serum-derived bovine immunoglobulin/protein isolate (SBI), for diarrhea-predominant irritable bowel syndrome (IBS-D) [1]. The purpose of this chart review was to assess safety and clinical outcomes of SBI in refractory irritable bowel syndrome (IBS) patients. Methods: A retrospective review of 35 IBS patients with diarrhea or mixed diarrhea/constipation pattern (IBS-M) who were administered SBI 5 grams twice daily was performed. Clinical response (“good response” or “no response”) and adverse events were determined by follow-up after four weeks of therapy. Patients were included for evaluation if a lactulose breath test (LBT) had been performed prior to SBI. All patients were refractory to common IBS therapies. The response rate to the inclusion of SBI was calculated in three separate groups: dividing patients based on their LBT results (positive or negative), dividing patients by their IBS diagnosis (IBS-D or IBS-M) and grouping all patients together. Results: Analysis was carried out on 26 IBS-D/-M patients with LBT results. Two patients were lost to follow-up and were excluded from data analysis. The positive LBT group (N = 11) had a 73% (p = 0.117) positive response rate to SBI. The negative LBT group (N = 13) had a significant response rate of 77% (p = 0.040). If patients were divided by IBS diagnosis or grouped together, the response rate to SBI was similarly ranging from 69% - 88%. Adverse events leading to cessation of SBI occurred in 3 of 24 patients. Conclusion: SBI appeared to be a safe and effective nutritional moiety in refractory IBS-D and IBS-M patients. Larger, double-blind studies are needed.