Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome

Abstract

BACKGROUNDThere is increased interest in combining nutritional modalities with pharmacological therapies for managing patients with diarrhea-predominant IBS (IBS-D).AIMA randomized, double-blind, placebo-controlled study to evaluate the impact of oral serum-derived bovine immunoglobulin/protein isolate (SBI) on gastrointestinal symptom scores and quality of life (QoL) in subjects with IBS-D.METHODSStudy subjects previously diagnosed with IBS-D according to ROME II criteria were recruited from London, Ontario, Canada and assigned to receive 5 g/day SBI, 10 g/day SBI, or placebo for 6 weeks. Daily symptom frequency and severity scores and a modified IBS-36 questionnaire assessed the impact of nutritional intervention. Laboratory assessments were performed at screening and end of treatment (EOT) to evaluate safety. Within-group comparisons of changes in number of days per week with symptoms and symptom severity were conducted on the per-protocol population of subjects using a t-test.RESULTSSubjects who received SBI at 10 g/day (N = 15) had statistically significant within-group reductions in abdominal pain (p < 0.01), loose stools (p < 0.01), bloating (p < 0.05), flatulence (p < 0.01), urgency (p < 0.05) and any symptom (p < 0.01) at EOT vs. baseline. Subjects receiving 5 g/day of SBI (N = 15) realized statistically significant within-group reductions in days with flatulence (p < 0.035), incomplete evacuation (p < 0.05), and any symptom (p < 0.01). There were no significant changes in QoL scores or in hematology or clinical chemistry among treatment groups.CONCLUSIONSThis pilot study showed that nutritional therapy with either 10 g/day or 5 g/day of SBI in 30 patients was well tolerated and resulted in statistically significant within group improvements in both symptom days and in daily symptom scores in subjects with IBS-D. Additional studies are underway with larger numbers of subjects to validate these findings.

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

“…Consideration for the Use of SBI Therapy SBI was considered in these two cases where the patients presented with PI-IBS-D following a C. difficile infection (CDI) based upon several factors including indication for patients with IBS-D [19] , mechanism of action [21] , microbial binding [22][23][24] , and general clinic practice experience. Antibiotic therapy is a major cause of antibioticassociated diarrhea and results in increased risk for CDI as well as persistent concurrent alteration of gut flora [25] .…”

“…FODMAP diets help address discomfort, bloating and flatulence by minimizing the ingestion of certain sugars and vegetables [17] . SBI (EnteraGam) is a prescription medical food product intended for the clinical dietary management of patients with chronic loose and frequent stools who have a limited or impaired capacity to ingest, digest, absorb, or metabolize certain nutrients used under physician supervision [18] , and specifically for patients with IBS-D [19] , IBD [18] , or HIV-associated enteropathy [20] .…”

“…SBI has been shown to also neutralize hypervirulent ribotype toxins from C. difficile including 027A/B, 078A/B and 087B in cell assays [24] . Such mechanisms may help to stabilize microbiota, maintain a homeostatic immune environment in the intestine, manage gut barrier function, and promote increased nutrient metabolism and utilization with this nutritional agent [19,20,29] . Together, the mechanisms of SBI (Figure 1) may be effective in management of the chronic loose and frequent stools brought on by PI-IBS while helping to provide a normal microbiota environment which may help avoid recurrent C. difficile infections.…”

“…The mechanism of action of SBI is postulated to involve binding to microbial components, maintaining immune balance in the gastrointestinal tract, restoring normal expression of tight junction proteins including Claudin-1 ( Figure 1) which assists in managing gut barrier function and improving nutrient uptake [21] . Clinical studies have demonstrated that SBI is safe and improves gastrointestinal symptoms (e.g., chronic loose and frequent stools, abdominal discomfort, bloating, and urgency) in patients with IBS-D [19] and HIV-associated enteropathy [20] . SBI is a specially-formulated protein source consisting of >90% protein of which >50% is immunoglobulin G (IgG) [18] .…”

Treating Irritable Bowel Syndrome: A Fresh and Minty Approach to an Old Therapy

“…It is different than other drugs as it is not subject to approval by the FDA, but rather that the food facility producing it is registered and subject to ''Good Manufacturing Practices'' under FDA regulatory statutes. There are special labeling requirements such as that the product must contain ingredients that are [19]. Although this PO preparation appears to be promising for the treatment of IBS, it does not supplant what are considered the most effective comprehensive therapeutic tools for IBS such as symptom validation, empathy, and optimal clinician-patient interactive skills along with sound dietary counseling and the achievement of better sleep quality and more exercise, combined at times with cognitive behavioral therapy.…”