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

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.

Case Series of 10 Drug-Refractory IBS Patients Who Respond to Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI)

Aim: The responses of 10 patients with long-standing, symptomatic, intractable drug-refractory histories of irritable bowel syndrome with diarrhea (IBS-D) and with abdominal pain, gas/bloating and distention, termed IBS undefined (IBS-U), were evaluated when administering a medical food product containing serum-derived bovine immunoglobulin/protein isolate (SBI). Methods: Patients in this case series were chosen based on their lack of satisfactory response to a variety of drugs, including antidiarrheal and antispasmodic medications, serotonin 5-HT3 receptor antagonists, selective serotonin re-uptake inhibitors (SSRIs), proton pump inhibitors (PPIs), antibiotics, and antidepressive drugs. Patients met Rome III criteria and were administered 5 g/day of SBI as standard-of-care nutritional support. A scale of 0% - 25%, 25% - 50%, 50% - 75%, 75% - 100% response to SBI was used for patient-reported improvement in overall IBS symptoms following administration for one month. Exact methods for calculating confidence intervals and p-values were used to assess complete management of symptoms and response to therapy. Adverse events were also monitored for this nutritional product. Results: The onset of gastrointestinal (GI) symptom reduction utilizing nutritional management with SBI occurred within an average time of 2-4 weeks with improved or near complete management in all 10 patients who were refractory to previous drug therapies by 4 weeks. When prompted, patients reported significant IBS symptom improvement which averaged between 50% - 100% (p = 0.002) with an average for complete management in all patients of 69%. No side effects were reported after SBI administration even when taken for up to 28 weeks. Conclusion: Based on the safety profile and reported outcomes in this case report, SBI should be considered as a nutritional option for management in IBS-D and IBS-U.