The product information provided in this site is intended for residents of the United States.

What is EnteraGam®?

EnteraGam® is a medical food product for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, such as irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD).

EnteraGam® is a fine powder that can be easily mixed into at least 4 ounces of liquid (water or other liquid as preferred). Or, EnteraGam® can be mixed with soft foods, such as pudding or yogurt. Some people notice management of their condition with EnteraGam® in as little as 2 to 4 weeks.1

EnteraGam® is not a probiotic

Probiotics contain live bacteria and may be sold without a prescription in grocery and health food stores as dietary supplements, drinks, or fermented foods. Probiotic manufacturers do not have to prove that their products are safe, pure, or potent.2

Probiotics add more bacteria to the intestinal environment. But they do not prevent the toxic substances released by bacteria and other microbial components from penetrating the lining of the intestine, which may contribute to abdominal discomfort, bloating, and chronic diarrhea and loose stools due to specific intestinal disorders.3,4

Probiotics may also be harmful for people who have a weakened immune system and are at risk of getting infections because their bodies cannot defend against illnesses or other medical problems.2

EnteraGam® is not an antibiotic

Antibiotics can also contribute to chronic diarrhea and loose stools by damaging the microbiome, which can lead to gut barrier disruption or leaky gut.5,6

How EnteraGam® differs

EnteraGam® uniquely binds toxic substances released by bacteria (and other substances called microbial components)7 that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine and causing problems. Importance of the Gut Microbiome can help you learn more about the intestinal environment.

In a clinical study, people who took EnteraGam® experienced fewer days per week with loose stools and other IBS-D–related symptoms, including abdominal discomfort and bloating. Some people notice management of their condition with EnteraGam® in as little as 2 to 4 weeks.1

Works only where it’s needed

Unlike some drugs that can affect the whole body, EnteraGam® is not absorbed systemically. This means that EnteraGam® works only where it’s needed in the gastrointestinal tract to manage chronic diarrhea and loose stools due to specific intestinal disorders, like IBS-D or IBD. It may also explain why EnteraGam® has8:

  • No reported interactions with any other medications
  • No reports of serious side effects

Plus, you can take EnteraGam® as long as you want (under a doctor’s supervision), and you do not need any special blood or monitoring tests with EnteraGam®. You also do not have to worry about bacterial resistance with EnteraGam®.8

Ask your doctor if EnteraGam® is right for you

Print this free Doctor Discussion Guide to start the conversation with your doctor.

*Medical foods are regulated by the FDA under the Orphan Drug Act9; specially formulated to be consumed or administered orally or enterally; to be used under physician supervision as part of ongoing care to ensure proper, safe use; specifically for management of distinctive nutrient needs, resulting from a specific chronic condition or disease; and specially formulated and processed, as results are not achievable by normal dietary intake.

References
  1. Wilson D, Evans M, Weaver E, Shaw AL, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013;6:49-60.
  2. Boyle RJ, Robins-Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks? Am J Clin Nutr. 2006;83(6):1256-1264.
  3. Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
  4. Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.
  5. McFarland Epidemiology, risk factors and treatments for antibiotic-associated diarrhea. Dig Dis. 1998;16(5):292-307.
  6. Barbut F, Meynard Managing antibiotic associated diarrhoea. BMJ. 2002;324(7350):1345-1346.
  7. Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; April 26-30, 2014; San Diego, CA.
  8. EnteraGam [product information]. Ankeny, IA: Entera Health, Inc.; October 2016.
  9. Frequently asked questions about medical foods; second edition. Guidance for industry. US Food and Drug Administration Web site. http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM500094.pdf. Accessed February 9, 2017.

Intended Use

EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.

Important Safety Information:

EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.

Please see full Product Information

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.