Entera Health, Inc. Announces the Publication of a Case Report that Summarizes a Positive Response to Oral Administration of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in a Patient with Chronic Diarrhea.
Entera Health, Inc. announced today the publication of a new case report in the journal Clinical Medicine Insights: Gastroenterology, supporting the benefits of EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) in a patient with chronic diarrhea and fecal incontinence related to chronic mesenteric ischemia. Authors include: Larry Good, MD (Lynbrook, NY USA) and Bruce P. Burnett, PhD (Cary, NC USA).
This retrospective case analysis describes a patient with chronic mesenteric ischemia who for more than two decades had experienced severe watery diarrhea with six to eight bowel movements per day, nocturnal diarrhea, and extreme urgency as well as frequent episodes of fecal incontinence (FI). A variety of treatments were unsuccessful in ameliorating his gastrointestinal symptoms. Within four weeks of initiating therapy with SBI, the patient experienced a dramatic amelioration of symptoms, reporting a marked reduction in urgency to defecate, stool frequency (passing two to three soft, semi-formed stools daily), and episodes of nocturnal diarrhea or incontinence. His sense of well-being has improved dramatically as demonstrated by his renewed ability to go on vacations and resume a more active social life. This case underscores how a safe, nutritional therapy may offer a new modality for physicians to address chronic FI in patients with difficult-to-manage gastrointestinal conditions such as chronic mesenteric ischemia.
About Chronic Mesenteric Ischemia
Chronic mesenteric ischemia (CMI) is a rare condition resulting from long-standing atherosclerotic disease of multiple mesenteric vessels and is three-fold more frequent in women than men over the age of 60 . Decreased perfusion of blood supply to the intestine in CMI leads to ischemia and inflammation. Typical symptoms of CMI are postprandial abdominal pain, weight loss, nausea, vomiting, fear of food ingestion, and diarrhea.
About Fecal Incontinence
Fecal incontinence (FI) is defined as the involuntary discharge of gas and/or fecal matter and is a severe and debilitating condition which affects over 18 million adults in the United States . About 2-3% of all adults are affected by FI , which increases to about 10% in elderly populations . The condition leads to significant costs to both the patient and the healthcare system, is reported to be under diagnosed, and has a dramatic impact on quality of life (QoL). Medical treatments for FI are currently limited, with the primary goal being directed at reducing the number of stools per day and improving stool consistency rather than factors that may cause the condition.
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
Citations: 1. Chang JB, Stein TA. Mesenteric ischemia:acute and chronic. Ann Vasc Surg. 2003;17(3):323-8. 2. Whitehead WE, Borrud L, Goode PS, et al. Fecal incontinence in U.S. adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512-517. 3. Perry S, Shaw C, McGrother C, RJ Matthews, RP Assassa, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut. 2002;50:480-48. 4. Crome P. Prevalence of faecal incontinence. Age Ageing. 2002;31:322.