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Serum-derived bovine immunoglobulin/protein isolate

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Serum-derived bovine immunoglobulin/protein isolate (SBI) is a medical food product derived from bovine serum obtained from adult cows in the United States. It is sold under the name EnteraGam.

EnteraGam (SBI) is intended for the dietary management of chronic diarrhea and loose stools. It must be administered under medical supervision. It is used to manage chronic loose or frequent stools in any condition or disease where diarrhea is chronically present, such as in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD), small intestinal bacterial overgrowth (SIBO), recurrent Clostridioides difficile-infection associated diarrhea, microscopic colitis or HIV-related enteropathy as well as many other diseases and conditions resulting in chronic diarrhea. EnteraGam is manufactured by Entera Health and distributed by RedHill Biopharma.

The overall AE rate (Adverse Events rate) is less than 0.4%. The most common AEs reported by patients administered EnteraGam include mild constipation (23), headache (13), mild diarrhea (11), nausea (8), abdominal pain (8), abdominal distention (7), and hives (7).

Mechanism of Action

Unlike common dietary proteins, SBI contains a concentrated source of ~60 immunoglobulin (>50% IgG, 1% IgA, and 5% IgM), 5% albumin and other proteins and peptides that may aid in the management of chronic diarrhea or loose and frequent stools. Immunoglobulins found in SBI have been shown to bind to microbial components with immune-activating potential from a variety of bacteria, fungi and viruses, including those implicated in human disease. The putative mechanism of action features, this binding of inflammatory antigens may prevent their passage into the lamina propria of the bowel wall, presumably due steric exclusion. The resultant dampening of immune response in the gut-associated lymphoid tissue (GALT) is believed to allow for restoration of intestinal homeostasis, leading to resumption of normal gut function and nutrient absorption.

The therapeutic effect of SBI's action on various GI conditions with chronic diarrhea provides a specific nutritional benefit that cannot be provided by normal dietary proteins alone or by increased intake of foods which contain immunoglobulin (i.e., meat, dairy).

Medical uses

In humans, oral immunoglobulins may improve function in the gastrointestinal (GI) tract. Conditions like HIV-enteropathy, IBS-D (irritable bowel syndrome with diarrhea), SIBO (small intestine bacterial overgrowth), recurrent C. difficile infection-associated diarrhea and post-infectious IBS-D often limit or impair the body's ability to absorb and digest select nutrients including water. Clinical studies have indicated that serum-derived bovine immunoglobulin/protein isolate may help to reduce diarrhea and to restore the ability of the GI tract to properly absorb and utilize those nutrients.

History

Research into bovine- and porcine-associated sources of immunoglobulin began in the field of animal health. Studies examined the health effects of adding immunoglobulins to the feed of  early-weaned piglets that had developed intestinal inflammation, intestinal barrier dysfunction, and general malnutrition causing the piglets not to thrive. These issues often manifested in diarrhea, dehydration, and death for young piglets. The addition of immunoglobulin-rich protein isolates  to the piglets’ food improved digestion, metabolism, and feed intake, increasing lean muscle mass and protein utilization. Gastric infection and diarrhea were also reduced in the post-weaning phase.

References

  1. ^ "EnteraGam" (PDF). Archived from the original (PDF) on 2019-07-02. Retrieved 2018-09-29.
  2. Ciampa, B (February 2017). "The Emerging Therapeutic Role of Medical Foods for Gastrointestinal Disorders". Gastroenterology & Hepatology. 13 (2): 104–115. PMC 5402682. PMID 28450817.
  3. Horgan, A (April 26–30, 2014). "Serum-derived bovine immunoglobulin/protein isolate binds to pathogen associated molecular patterns". FASEB J. 28 (Suppl 1): 836.6. doi:10.1096/fasebj.28.1_supplement.836.6. S2CID 82087287.
  4. Detzel, CJ (April 2015). "Bovine immunoglobulin/protein isolate binds pro-inflammatory bacterial compounds and prevents immune activation in an intestinal co-culture model". PLOS ONE. 10 (4): e0120278. Bibcode:2015PLoSO..1020278D. doi:10.1371/journal.pone.0120278. PMC 4382133. PMID 25830826.
  5. ^ Petschow, Bryon W. (May 2014). "Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy". Clinical and Experimental Gastroenterology. 7: 181–90. doi:10.2147/CEG.S62823. PMC 4041178. PMID 24904221.
  6. ^ Petschow, Bryon W (January 2015). "Dietary Requirement for Serum-Derived Bovine Immunoglobulins in the Clinical Management of Patients with Enteropathy". Digestive Diseases and Sciences. 60 (1): 13–23. doi:10.1007/s10620-014-3322-0. PMC 4284400. PMID 25142170.
  7. Wilson, Dale (2013). "Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome". Clinical Medicine Insights: Gastroenterology. 6: 49–60. doi:10.4137/CGast.S13200. PMC 4020402. PMID 24833942.
  8. Arrouk, R (2017). "Serum-derived bovine immunoglobulin (SBI) for children with diarrhea predominant irritable bowel syndrome (d-IBS)". Naspghan.
  9. Rana, A (Apr 2017). "Tolerability, and efficacy of serum-derived bovine immunoglobulin in children with diarrhea-predominant irritable bowel syndrome". Gastroenterology. 152 (5): S652. doi:10.1016/S0016-5085(17)32299-0.
  10. Crawford, C (2015). "Post-infectious irritable bowel syndrome with functional diarrhea following C. difficile infections: Case studies of responses using serum-derived bovine immunoglobulin". Gastro and Hepatology Res. 4 (4): 1577–81. doi:10.17554/j.issn.2224-3992.2015.04.483.
  11. Shaw, AL (2017). "Impact of serum-derived bovine immunoglobulin/protein isolate therapy on irritable bowel syndrome and inflammatory bowel disease: A survey of patient perspective". Patient Prefer Adherence. 11 (1001): 1001–1007. doi:10.2147/PPA.S134792. PMC 5460652. PMID 28615929.
  12. Valentin, N (2017). "A. Potential mechanisms of effects of serum-derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea-predominant irritable bowel syndrome". Physiol Rep. 5 (5): e13170. doi:10.14814/phy2.13170. PMC 5350178. PMID 28275113.
  13. Shafran, I (2015). "Management of inflammatory bowel disease patients with oral serum-derived bovine immunoglobulin". Ther Adv Gastroenterol. 8 (6): 331–9. doi:10.1177/1756283X15593693. PMC 4622288. PMID 26557889.
  14. Soriano, RA (2017). "Clinical and pathologic remission of pediatric ulcerative colitis with serum-derived bovine immunoglobulin added to standard treatment regimen". Case Rep Gastroenterol. 11 (2): 335–343. doi:10.1159/000475923. PMC 5471788. PMID 28626380.
  15. Ferm, S (2017). "Serum-derived bovine immunoglobulin as novel adjunct in complicated Clostridium difficile colitis treatment". ACG Case Reports Journal. 4: e64. doi:10.14309/crj.2017.64. PMC 5425282. PMID 28516109.
  16. Gelfand, MS (2017). "Oral serum-derived bovine immunoglobulin for management of infectious diarrhea due to norovirus and cryptosporidiosis in solid organ transplant patients". Infect Dis Clin Practice. 25 (4): 218–220. doi:10.1097/IPC.0000000000000479. S2CID 58879604.
  17. Arikapudi, S (2018). "Serum bovine immunoglobulin for chemotherapy-induced gastrointestinal mucositis". Amer J Hospice and Palliative Med. 35 (5): 814–817. doi:10.1177/1049909117735831. PMID 29020798. S2CID 4377545.
  18. Iduru S, Burnett BP.  Management of celiac disease and non-celiac gluten sensitivity with serum-derived bovine immunoglobulin/protein isolate. Poster presented (#1343) at 2015 ACG Annual Scientific Meeting, Honolulu, HI.  October 19, 2015.
  19. Kumar V, Zhou E, Yuliya A, Mansoor MS, Sharma P, Feuerstadt P. Serum-derived bovine immunoglobulin (SBI) is safe and well tolerated in patients with recurrent C. difficile infection (RCDI) treated medically. Poster (P100) Presented at American College of Gastroenterology Annual Meeting, Orlando, FL. October 15, 2017.
  20. Pierce, JL (December 2005). "Effects of spray-dried animal plasma and immunoglobulins on performance of early weaned pigs". Journal of Animal Science. 83 (12): 2876–85. doi:10.2527/2005.83122876x. PMID 16282627. S2CID 34153282.
  21. Peace, Ralph Michael (July 2011). "Spray-Dried Porcine Plasma Influences Intestinal Barrier Function, Inflammation, and Diarrhea in Weaned Pigs". Journal of Nutrition. 141 (7): 1312–7. doi:10.3945/jn.110.136796. PMID 21613450.
  22. van Beers-Schreurs, Hetty M.G (June 1998). "Weaning and the Weanling Diet Influence the Villous Height and Crypt Depth in the Small Intestine of Pigs and Alter the Concentrations of Short-Chain Fatty Acids in the Large Intestine and Blood". Journal of Nutrition. 128 (6).
  23. Torralladorna, David (2010). "Spray Dried Animal Plasma as an Alternative to Antibiotics in Weanling Pigs - A Review". Asian-Australasian Journal of Animal Sciences. 23 (1).
  24. Kuchibhatla, R (2015). "Nutritional impact of dietary plasma proteins in animals undergoing experimental challenge and implications for patients with inflammatory bowel disorders. A meta-analysis". Adv. Nutr. 6 (5): 541–51. doi:10.3945/an.114.007930. PMC 4561828. PMID 26374176.
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