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Thu, 21 Jan 2021 12:58:58 -0600
2015-04-21 Print

Evaluation of Immunoglobulin Isolate: Intestinal Cell Model

Entera Health, Inc. Announces the Publication of Research Using an Intestinal Co-Culture Model to Show How Immunoglobulins in Bovine Serum- Derived Protein Isolate Bind Pro-Inflammatory Bacterial Compounds and Prevent Immune Activation.


Entera Health, Inc. announced today a new scientific publication appearing in the journal PLOS One titled "Bovine Immunoglobulin/Protein Isolate Binds Pro-Inflammatory Bacterial Compounds and Prevents Immune Activation in an Intestinal Co-Culture Model." Authors include: Christopher J. Detzel (Ankeny, IA), Alan Horgan (Ankeny, IA), Abigail L. Henderson (Ankeny, IA), Bryon W. Petschow (Cary, NC), Christopher D. Warner (Ankeny, IA), Kenneth J. Maas (Ankeny, IA), and Eric M. Weaver (Ankeny, IA).

The studies described in this report used a cell culture model of the intestinal epithelium to investigate the mechanisms by which oral immunoglobulin preparations may impart benefits to patients with intestinal disorders. The secretory IgA immunoglobulin is known to protect the intestine, but little is known about the potential effects of IgG and IgM. Using a modified ELISA method, this study showed that several immunoglobulin isotypes (IgG, IgA, and IgM) bind bacterial cell wall antigens that are commonly found in the intestinal lumen (LPS, Lipid A). More importantly, this binding of bacterial antigens also inhibited the production of inflammatory cytokines from THP-1 monocytes, a type of immune cell; such an effect is known as "immune exclusion." A second mechanism was demonstrated in other experiments using the co-culture model when immunoglobulins in SBI bound to another model antigen (known as Pam3CSK4) which created a larger complex that was no longer able to pass through a damaged epithelial barrier. This mechanism is referred to as "steric exclusion." These studies demonstrate a role for IgG and IgM in SBI in acting through immune and steric exclusion mechanisms in the intestinal lumen, which expands our understanding of how SBI can effectively manage intestinal homeostasis.



About Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI):
Serum-derived bovine immunoglobulin/protein isolate (SBI) is a specially formulated protein preparation that includes >50% immunoglobulin G (IgG) along with other proteins and peptides that reflect the composition of plasma and are similar to proteins found in colostrum and milk. Clinical studies have shown that SBI improves symptoms, nutritional status, and various biomarkers associated with enteropathy in patients with diarrhea-predominant IBS (IBS-D) or HIV infection (1,2). Previous studies have demonstrated that SBI binds various microbial components (3), which may have downstream effects in maintaining GI immune balance and managing gut barrier function, which ultimately leads to improved nutrient utilization.

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

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


1. Asmuth, D. M., et al. (2013) Oral Serum-Derived Bovine Immunoglobulin Improves Duodenal Immune Reconstitution and Absorption Function in Patients with HIV Enteropathy. Aids 27, 2207-2217.

2. Wilson, D., et al. (2013) Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome. Clinical Medicine Insights: Gastroenterology 6, 49-60.

3. Navarro A, et al. (2007) Common epitopes in LPS of different Enterobacteriaceae are associated with an immune response against Escherichia coli O157 in bovine serum samples. Journal of Medical Microbiology. 56:1447-54.

Contact Info
Tom Heck
2000 Regency Parkway 
Suite 255 
Cary, NC 27518 

Phone: 515-963-7560