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 pvalues 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 * Corresponding author. R. Hilal et al. 322 this case report, SBI should be considered as a nutritional option for management in IBS-D and IBS-U.

Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin

“…2013]. In addition, case studies of SBI report management in drug-refractory IBS-D patients in real-world settings [Hilal et al . 2014; Weinstock and Jasion, 2014; Good et al .…”

“…Clinically, SBI has been shown to reduce symptoms of abdominal discomfort, flatulence, bloating, loose stools and urgency in IBS-D [Wilson et al 2013] as well as loose stools, cramping, urgency, incontinence and nocturnal bowel movements in HIV-associated enteropathy [Asmuth et al 2013]. In addition, case studies of SBI report management in drug-refractory IBS-D patients in real-world settings [Hilal et al 2014;Weinstock and Jasion, 2014;Crawford and Panas, 2015]. Recent case series utilizing SBI in CD and UC patients to achieve clinical remission in patients who were not fully managed by traditional drug therapies [Awad and Jasion, 2015; as well as potential endoscopic remission [Beauerle et al 2015;Awad and Jasion, 2015].…”

Post-Infectious Irritable Bowel Syndrome with Functional Diarrhea Following C. difficile Infections: Case Studies of Responses Using Serum-Derived Bovine Immunoglobulin

“…Approximately 25-50% of orally administered IgG survives digestion in the stomach and small intestine [18] . In clinical practice, SBI has been used in numerous patients as a therapeutic option to help manage chronic loose and frequent stools in patients as well as patients with IBS-D [26,27] . While SBI may not be effective in all patients, clinical experience would suggest that SBI is safe and effective in many patients with chronic loose and frequent stools.…”

Oral serum bovine immunoglobulin improves IBS-D symptoms analyzed from patient medical charts.

“…One patient withdrew due to metallic taste, mouth sore and nausea. In recent retrospective reports of SBI use collected from medical charts, there was approximately a 70% overall response rate to therapy in drug-refractory IBS-D patients [17][18][19][20]. For example, Hilal et al [17] and Good et al [18] reported patients with IBS-D, IBS-M, and IBS with bloating had about 75% overall management of their condition.…”

“…In colitis animal models, SBI consumption led to decreased proinflammatory cytokine and chemokine production, increased anti-inflammatory proteins, and attenuated tissue damage [12][13][14]. SBI has also been tested in a randomized controlled trial, an open label study and several case series in IBS-D patients [15][16][17][18][19][20][21].…”