New Clinical Data About EnteraGam® Reported at the ACG 2015 Annual Meeting
New Clinical Data Utilizing EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) for Chronic Loose and Frequent stools in a Variety of Intestinal Conditions Presented at the ACG 2015 Annual Meeting
Ankeny, United States – October 27, 2015 /MarketersMedia/ —
Entera Health, Inc. today announced results from nine poster presentations at the ACG 2015 Annual Meeting in Honolulu, HI, from Friday, October 16th to Wednesday, October 21st, 2015.
Read Full Summaries with Outcomes
Diarrhea Management
Dr. Christine Frissora (Weill Cornell Medical College, Cornell University, New York, NY) reported on a retrospective chart review of seven patients with refractory microscopic colitis (MC) that were placed on SBI therapy to manage chronic loose and frequent stools.
Dr. Michael LeVine (Atlanta Gastroenterology Associates, Atlanta, GA) and Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY, USA) presented chart reviews on four patients given SBI for antibiotic-associated diarrhea (AAD) following infection with C. difficile.
Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY, USA) reported on a patient with severe intractable diarrhea (13-14 watery stools per day) and fecal incontinence (FI) following surgery to create an ileorectal anastomosis.
Dr. Raouf Hilal (University of Central Florida College of Medicine Orlando, FL) conducted a chart review of six patients with chronic pancreatitis or pancreatic insufficiency that were given SBI to determine its effect on chronic loose and frequent stools and other commonly reported symptoms.
Dr. Mark Anderson (Boice-Willis Clinic, Rocky Mount, NC) reported on a patient of his and Dr. Mitchel Mah’moud’s (Duke University School of Medicine, Durham, NC) with a 4-week history of diarrhea (~10 stools/day) both during treatment with Disease Modifying Anti-Rheumatic Drugs (DMARD; e.g. methotrexate) and after DMARDs were discontinued.
Jason Roy, ARNP, (Central Florida Gastroenterology, Orlando, FL) presented results from a retrospective chart review of eight patients given SBI to help manage chronic intractable diarrhea associated with mastocytic enterocolitis (i.e. abdominal pain and diarrhea correlated with high mast cell localization in the colon).
Celiac Disease
Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY) presented results from a retrospective chart review of a patient with celiac disease and poor adherence to a gluten-free diet to assess the response to SBI when added to her management therapy.
Dr. Satish Iduru (GI Specialists of Houston, Houston, TX) reported on the use of SBI in another patient with celiac disease and a second one with non-celiac gluten sensitivity (NCGS).
Hepatic Encephalopathy (HE)
Dr. Fred Fowler (Carolina Digestive Health, Charlotte, NC) presented a case report on nine patients with cirrhosis and mild to moderate overt HE. Eight of the nine patients showed improvement in cognitive function, while five patients showed successful management of asterixis through 3 months following the addition of SBI to their current therapeutic regimen.
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 the product website at http://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 women or nursing mothers. The choice to administer EnteraGam® in pregnant women 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. The staff’s passion is to help people thrive through healthier living. The staff’s motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Learn more at http://www.enterahealth.com.
For more information about us, please visit http://enterahealth.com
Contact Info:
Name: Tom Heck
Organization: Entera Health, Inc.
Address: 2000 Regency Parkway, Suite 255, Cary, NC 27518
Phone: 515-963-7560
Release ID: 94283
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