Entera Health, Inc. Announces the Publication of a Scientific Article Summarizing Positive Responses to Oral Administration of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in 10 Patients with Drug-Refractory IBS
Entera Health, Inc. announced today the publication of a new case series report in the Open Journal of Gastroenterology (OJG), October 23, 2014, of EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) or alternating between constipation and diarrhea (IBS-M) that were refractory to common IBS therapies. Authors include: Leonard B. Weinstock, MD (St. Louis, MO USA) and Victoria S. Jasion, PhD (Cary, NC USA).
In this retrospective review, 35 patient charts were initially reviewed. Twenty-six patients met criteria for analysis of either being lactose breath test (LBT) positive or negative for comparison. Safety and clinical outcomes were analyzed for 24 patients with IBS-D or mixed diarrhea/constipation pattern IBS (IBS-M) who were refractory to IBS therapies and had previously been screened for small intestinal bacterial overgrowth (SIBO) using a lactose breath test (LBT). Two patients were lost to follow-up. Among patients who had a negative LBT result, 77% reported a positive response to SBI therapy (N = 13; p =0.04), while 73% of patients with a positive LBT result reported a positive response to SBI therapy (N = 11; p = 0.117). Similar results were obtained when patients were separated based on their diagnosis; IBS-D patients had a 69% response rate to SBI (N=16; p = 0.121) and IBS-M patients had a significant response rate of 88% to SBI therapy (N = 8; p = 0.015). When all patients were pooled (N = 24), the response rate to SBI therapy was 75% (p = 0.01). Adverse events leading to cessation of SBI occurred in 3 of 24 patients included constipation (1), diarrhea (1) and nausea and constipation (1). These results suggest that SBI provides for a distinctive nutritional requirement for management of chronic loose and frequent stools in patients whether they are LBT positive or negative after a diagnosis of SIBO. The article can be accessed at:http://www.scirp.org/journal/PaperInformation.aspx?PaperID=50770#.VElAT_nF81I
About Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Irritable bowel syndrome (IBS) is a complex and commonly diagnosed gastrointestinal (GI) disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits that negatively affects patients’ daily activities and quality of life. Symptoms may include abnormal stool form or frequency, defecation straining, bloating, urgency, feelings of incomplete bowel movement, and passing mucus. Population-based studies indicate that the worldwide prevalence of IBS is approximately 10% to 20%. While the cause of IBS is still largely unknown, a variety of factors have been considered to play a role, including genetics, diet, infections, psychosocial factors, and changes in gut motility or barrier function. Recent studies have also highlighted the potential role of low grade inflammation, often in association with alterations in the microbiota composition or metabolism, which may cause changes in gut barrier function with increased permeability and subsequent malabsorption of water, electrolytes, and nutrients. Such factors or host system changes can lead to alterations in nutritional status, which can further contribute to symptoms. Unfortunately, most therapies that are currently used to manage patients with IBS are aimed at lessening symptoms rather than the underlying cause of the disorder, which has led to an increased interest in multi-modal therapeutic approaches aimed at restoring intestinal health and nutritional status.
EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy [e.g., in diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy]. EnteraGam™ is required to be used under physician supervision as part of ongoing medical care for a specific condition or disease. EnteraGam™ is also indicated for the clinical dietary management of enteropathy in patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients. For full prescribing information, please visit our product website at www.enteragam.com.
Important Safety Information
EnteraGam™ is a specially formulated protein source for the management of intestinal disorders. The product has been extremely well tolerated for up to a year in HIV patients and up to 8 months in infants. The major side effects in clinical trials (2-5%) have included mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam™ is contraindicated for patients with a hypersensitivity (allergy) to beef, or any components in EnteraGam™. Therefore, patients who have an allergy to beef or any component of EnteraGam™ should not take this product. EnteraGam™ has not been studied in pregnant and nursing mothers. The choice to administer EnteraGam™ in pregnant or nursing mothers is at the clinical discretion of the physician. Medical foods like EnteraGam™ are required by FDA regulations to be dosed and monitored by physicians as part of ongoing care for patients with chronic conditions or diseases.
About Entera Health, Inc.
Entera Health, Inc. is focused on improving worldwide health through the development of clinically safe biotherapeutics to address unmet needs. Our passion is to help people thrive through healthier living. Our motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Visit us at www.enterahealth.com.
For questions, please contact:
Tom Heck, Chief Operating Officer