CASE REPORT: ORAL IMMUNOGLOBULINS AND POST-INFECTIOUS IBS

Entera Health, Inc. announces the publication of a new clinical case report in the Journal of Gastroenterology and Hepatology Research, summarizing the benefits of EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) in two patients with histories of post-infectious irritable bowel syndrome with diarrhea (IBS-D). Authors include: Carl Crawford, MD (New York Presbyterian-Weill Cornell Medical Center, New York, NY) and Raymond Panas, PhD (Cary, USA).

Intestinal infections caused by a variety of bacteria including Clostridium difficile can lead to post-infectious Irritable Bowel Syndrome (PI-IBS) with symptoms that resemble IBS with diarrhea (IBS-D) (1,2). This new case report evaluated the use of SBI in two patients who presented with PI-IBS following recurrent C. difficile infections (CDI) successfully treated with antibiotics but with residual diarrhea. The clinical decision for SBI use was based on recent evidence for management of chronic loose and frequent stools in patients with IBS-D [3,4]. The first patient, a Caucasian female with PI-IBS following recurrent CDI, was started on SBI after unsuccessful attempts at resolving symptoms with cholestyramine, diet modification, and anti-diarrheal agents. The patient reported improvement in symptoms of frequent loose stools and abdominal discomfort within 48 hours of starting SBI, allowing her to return to work. The second patient, also a Caucasian female, had a history of recurrent CDI and was placed on SBI after developing symptoms of chronic loose and frequent stools. The patient reported improved management of her bowel habits within a few days of starting SBI therapy and continues at 5 g/day for ongoing maintenance of her PI-IBS-D.

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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. The list includes, genetics, 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, that 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 addressing the underlying cause of the disorder. Consequently, there is an increased interest in multi-modal therapeutic approaches aimed at restoring intestinal health and nutritional status.

About EnteraGam®

EnteraGam® is a prescription medical food product intended to provide for distinctive nutritional requirements that are unique for the clinical dietary management of specific intestinal disorders [e.g., in irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), 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 http://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 http://www.enterahealth.com/.

For questions, please contact:
Tom Heck, Chief Operating Officer
515-963-7560
Tom.Heck@enterahealth.com

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