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

Abstract

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.