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FAQs About EnteraGam®
General product information
What is EnteraGam®?
EnteraGam® is a medical food product for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders like irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD). Read About EnteraGam® to learn more.
What is medical food?
How can EnteraGam® help?
EnteraGam® uniquely addresses the underlying factors that may contribute to chronic diarrhea and loose stools in people with specific intestinal disorders, like IBS-D or IBD. Print this free Doctor Discussion Guide to help you talk to your doctor about EnteraGam®.
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.9 See how EnteraGam® works.
How many packets are in a box?
Each box of EnteraGam® has 30 packets in it.
What is the bacteria count in millions in a packet of EnteraGam®?
Is EnteraGam® safe?
Why must EnteraGam® be taken under physician supervision? Can it be dangerous?
EnteraGam® is classified as a medical food, which is the gold standard for safety and must be administered under physician supervision because it is used for chronic diseases such as IBS-D and IBD.
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How it works
How does EnteraGam® work?
EnteraGam® uniquely binds toxic substances released by bacteria (and other substances called microbial components1) that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine and causing problems.
EnteraGam® may also help:1-8
- Restore a stable environment in your gut (called gut homeostasis)
- Manage how your gut barrier works (called gut barrier function) so nutrients from foods and fluids can be properly absorbed
See EnteraGam® for Chronic Diarrhea, EnteraGam® for IBS-D or EnteraGam® for IBD to learn more.
If Cholestyramine has helped in the past, do you think EnteraGam® will help now?
EnteraGam® works differently by targeting the root cause of chronic loose stools in the gut by binding and removing pathogenic bacteria before they can cause an inflammatory response.
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Symptoms
Does EnteraGam® help with gas?
In a randomized placebo-controlled trial, EnteraGam® was shown to reduce the number of days with IBS-D symptoms such as flatulence by 35%.
Can EnteraGam® be used for diarrhea that comes from c difficile?
The concentrated antibodies in EnteraGam® specifically bind to c. difficile, making it a great treatment option for diarrhea associated with c. difficile infection.
Is EnteraGam® still helpful to patients even if they don’t have diarrhea/loose stools?
Absolutely, EnteraGam® helps maintain gut barrier function, which has many positive effects. In a randomized placebo-controlled trial, EnteraGam® significantly decreased the number of days patients experience abdominal discomfort, urgency, bloating, and flatulence.
Can EnteraGam® be used for constipation?
IBS-C is currently not part of the labeled intended use for EnteraGam®. Therefore, use in this patient population is up to the patient’s physician. We do not have any formal clinical data in IBS-C patients, though we reported some IBS-C patient responses in case studies. Since EnteraGam® is intended for patients with chronic loose and frequent stools, and it does cause mild constipation in clinical studies (2-5%), it may not be appropriate for IBS-C patients.
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Conditions
Can EnteraGam® be used for IBS with constipation?
IBS-C is currently not part of the labeled intended use for EnteraGam®. Therefore, use in this patient population is up to the patient’s physician. We do not have any formal clinical data in IBS-C patients though we reported some IBS-C patient responses in case studies. Since EnteraGam® is intended for patients with chronic loose and frequent stools, and it does cause mild constipation in clinical studies (2-5%), it may not be appropriate for IBS-C patients.
Does EnteraGam® help with leaky gut?
EnteraGam® is indicated for the dietary management of chronic loose and frequent stools related to IBS-D. It has been shown to help manage gut barrier function which may lead to improvements with leaky gut symptoms such as loose stools, flatulence, and bloating.
Does EnteraGam® help with a bowel obstruction?
EnteraGam® has not been extensively studied in patients with bowel obstruction. Please consult your doctor.
Will EnteraGam® work for a person with microscopic colitis?
EnteraGam® is a great addition to the standard of care for patients with IBD, such as microscopic colitis, Crohn’s disease, and ulcerative colitis.
Will EnteraGam® work for a person with hydrogen dominant SIBO?
Small intestinal bacterial overgrowth (or SIBO) can be caused by many things including: lack of proper stomach acid production that can normally kill bacteria in the small intestine; infection by bacteria; and as part of other diseases and conditions (i.e., Crohn’s disease, IBS). SIBO patients experience IBS-like symptoms. We have performed one retrospective analysis on the effect of EnteraGam® (1 packet BID) on patients diagnosed with SIBO by lactulose breath test who were refractory to treatment with the antibiotic Xifaxan®. The study showed that EnteraGam® managed SIBO in 70% of these patients.
Will EnteraGam® help with H2S bacteria overgrowth?
EnteraGam® binds and removes a variety of antigens, but it has not been extensively studied in patients with hydrogen dominant SIBO. Please consult your doctor.
Will EnteraGam® work for a person with Crohn’s disease? Has it been studied in connection with Crohn’s?
EnteraGam® is a great addition to the standard of care for patients with IBD, such as microscopic colitis, Crohn’s disease, and ulcerative colitis.
Will EnteraGam® work for a person with terrible fibromyalgia pain post osteomyelitis and its treatment?
EnteraGam® has not been extensively studied in this patient population. Please consult your doctor.
Will taking EnteraGam® help with my lactose intolerance?
EnteraGam® is derived from bovine serum and is dairy and lactose-free, making it a great treatment option for patients who present with IBS-D or chronic loose and frequent stools who also have a problem digesting lactose. However, it will not act directly on the lactose tolerance of the patient or improve it in any way.
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Probiotics and antibiotics
How is EnteraGam® different from probiotics?
EnteraGam® is not a probiotic. Probiotics simply add bacteria to the intestinal environment. They may 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.11
Plus, probiotics do not work like EnteraGam® to prevent the toxic substances released by bacteria and other microbial components from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools due to specific intestinal disorders, like IBS-D or IBD.3,12 See About EnteraGam® to learn more.
How is EnteraGam® different from antibiotics?
EnteraGam® is not an antibiotic. Antibiotics can contribute to diarrhea by damaging the microbiome which leads to gut barrier disruption or leaky gut. Antibiotics are also not safe for long-term use for IBS-D, which is often a chronic condition.10 You can take EnteraGam® as long as you want, and you do not need any special blood tests or other monitoring tests. And with EnteraGam®, you do not have to worry about bacterial resistance like you do with antibiotics.8,10 See About EnteraGam® to learn more.
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Use with other health products
Can I use EnteraGam® with other therapies?
EnteraGam® can be safely taken along with other therapies for chronic diarrhea and loose stools that your doctor has prescribed. EnteraGam® can also be safely taken with any other medications or therapies for other conditions.8 Learn more about the safety of EnteraGam®.
Should I avoid using supplements when taking EnteraGam®?
There are no drug or supplement interactions with EnteraGam®. Therefore, it is okay to add it to your current supplement regimen.
Is taking probiotics together with EnteraGam® advised or contraindicated?
EnteraGam® has no direct effect on probiotics, however, they are used together quite frequently to improve digestive health.
Do you have any information on results or testimonials or reviews about people that take EnteraGam® with Humira®?
EnteraGam® is a great addition to the standard of care for patients with Crohn’s disease or ulcerative colitis who may be taking Humira®.
Can EnteraGam® be taken with Xifaxan®?
EnteraGam® has no drug-to-drug interactions and acts locally in the GI tract, making it a great addition to Xifaxan®.
Can I continue to take MiraLAX® while taking EnteraGam®?
EnteraGam is indicated for the management of chronic loose stools related to IBS-D. MiraLAX® is commonly used to manage constipation, and therefore you should consult your doctor about using both products together.
Can I continue taking Lactaid® while I take EnteraGam®?
EnteraGam® has no drug-to-drug or supplement interactions and therefore will have no effect on Lactaid.
Can EnteraGam® be taken with other commonly prescribed medications for IBS-D, such as Imodium®, probiotics, and dicyclomine?
EnteraGam® has no drug-to-drug or supplement interactions and therefore is a great addition to your current medication regimen to help manage chronic loose and frequent stools.
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Ingredients
What is the full ingredients list for EnteraGam® – active and inactive ingredients?
Each serving of EnteraGam® consists of:
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- 5 g of serum derived bovine immunoglobulin (SBI)
- 5 g of dextrose
- trace amounts of sunflower lecithin
Is EnteraGam® safe for a dairy-free, lactose-free, corn-free, soy-free diet?
Does EnteraGam® contain corn or corn-derived ingredients?
Does EnteraGam® contain nuts or nut-derived ingredients?
Is EnteraGam® gluten free?
Is there a vegetarian (non-animal based) version of this product?
What is the source of the dextrose in EnteraGam®?
Is there a dextrose-free version of EnteraGam® available or planned?
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Taking EnteraGam®
How do I take EnteraGam®?
EnteraGam® is a fine powder that can be easily mixed into at least 4 ounces of liquid (water or other liquid as preferred8). Or, EnteraGam® can be mixed with soft foods, such as pudding or yogurt.8 Get more tips for getting started on EnteraGam®.
How long can I take EnteraGam®?
How many packets a day is a patient supposed to take?
Patients taking EnteraGam® begin by taking 2 packets a day for the first two weeks, followed by a maintenance dosing protocol of 1 packet per day. In the most severe cases, you make take up to 4 packets per day. Please consult your doctor for the best treatment protocol for you.
Is it best to take EnteraGam® on an empty stomach or with food?
Either option is perfectly fine.
How much time after a dose of EnteraGam® can I eat?
There are no food requirements for taking EnteraGam®.
Should I take EnteraGam® with a snack during the day when I don’t have other vitamins & enzymes?
No food is required to take EnteraGam®.
Which is better/most recommended for the first 2 weeks: 1 twice daily or 2 once daily?
Patients taking EnteraGam® begin by taking 2 packets a day for the first two weeks, followed by a maintenance dosing protocol of 1 packet per day. In the most severe cases, you make take up to 4 packets per day. Please consult your doctor for the best treatment protocol.
Is it okay to mix two packages in one dose?
EnteraGam® can be dosed split up throughout the day or all in one dose.
When I split a package of EnteraGam®, how much is that per each of 2 servings? Is it 1 teaspoon?
One packet of EnteraGam® contains 5 grams of serum-derived bovine immunoglobulin and 5 grams of dextrose.
Is it okay to take EnteraGam® beyond its expiration date? If so, how far past? Is there a danger if taken far beyond the expiration date?
It is not recommended to take EnteraGam® past its posted expiration.
What is the reason EnteraGam® cannot be shaken? Is it ok to mix it with a hand blender?
When shaken, the product will produce foam at the top which is not ideal for consumption. EnteraGam® is best mixed into a solution by hand with a fork or spoon for 30 seconds.
When I mix EnteraGam® in water, there is always some foam left over at the bottom after I drink all the fluid. Is it imperative that I drink the foam in order to get the full dose?
No.
Does it really make it less effective if I mix EnteraGam® in a bottle and drink it 4 or more hours later?
It is recommended to take EnteraGam® as soon as it is mixed.
Is there any reason why I can’t put EnteraGam® into an empty gelatin capsule and take it with water?
No reason at all.
How long do I have to wait to drink hot liquids after I consume EnteraGam®?
You do not have to wait to consume hot beverages after taking EnteraGam®. However, it is not recommended to use hot beverages to mix EnteraGam® for consumption as the heat may denature the antibodies.
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Timing for taking EnteraGam®
Is EnteraGam® something you take every day or only during flare-ups?
EnteraGam® can be used acutely to battle a flare-up, however, most patients see the best results by taking EnteraGam® daily.
Should EnteraGam® be taken at the same time each day?
EnteraGam® can be taken at any time. It does not have to be the same time each day.
Should EnteraGam® be taken in the morning or evening?
EnteraGam® can be taken any time of the day. Whatever is best for the patient’s lifestyle.
Should EnteraGam® be taken before or after a meal?
There are no food requirements for taking EnteraGam®. Whatever is best for the patient’s lifestyle.
What is the best time of day to take EnteraGam® two times a day?
EnteraGam® can be taken any time of the day.
What is the best time of day to take EnteraGam® once a day?
EnteraGam can be taken any time of the day.
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What can be taken with EnteraGam®
Why should EnteraGam® not be mixed with citrus juice?
It was previously thought that the high acidity of citrus juices would negatively affect the antibodies in EnteraGam®. However, we now know that it has no effect on the product.
Is it best to take EnteraGam® with room-temperature water?
Is it okay to mix EnteraGam® with hot tea?
Is it okay to mix EnteraGam® with pudding?
Is it okay to mix EnteraGam® with applesauce?
Is it okay to mix EnteraGam® with (lactose-free) milk?
Is it okay to mix EnteraGam® with pineapple juice?
Is it okay to mix EnteraGam® with Cran-lite cranberry or other cranberry juice?
Is it okay to mix EnteraGam® with Pedialyte®?
Yes.
Is EnteraGam® something I can mix into my morning smoothie that contains fruit, greens & protein powder?
Yes.
Can EnteraGam® be taken at the same time as a powder glutamine supplement and/or a powdered probiotic? Can we mix EnteraGam® with either of these in the same liquid?
EnteraGam® has no drug or supplement interactions, making it a great addition to your current supplement regimen.
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Getting EnteraGam®
Where can I get EnteraGam®?
Use EnteraGam® personalized pharmacy services to get your EnteraGam® prescriptions filled. You can have your EnteraGam® prescription conveniently delivered right to your home—in just a few days—saving you trips to the pharmacy. Visit the EnteraGam® Hub to learn more. The Hub is where all of the important EnteraGam® patient services and information come together in one place for your convenience.
If you still have questions about EnteraGam®, contact us and we’ll be happy to answer any additional questions you may have.
References
- 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.
- Asmuth D, Netanya S. Utay NS, Somsouk M, et al. Oral bovine immunoglobulin reduces immune activation in HIV+ immune nonresponders. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.
- Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
- Henderson AL, Brand MW, Darling RJ, et al. Attenuation of colitis by serum-derived bovine immunoglobulin/protein isolate in a defined microbiota mouse model. Dig Dis Sci. 2015;60(11):3293-3303.
- Pérez-Bosque A, Miró L, Maijó M, et al. Dietary intervention with serum-derived bovine immunoglobulins protects barrier function in a mouse model of colitis. Am J Physiol Gastrointest Liver Physiol. 2015;308(12):G1012-G1018.
- Pérez-Bosque A, Miró L, Maijó M, et al. Oral serum-derived bovine immunoglobulin/protein isolate has immunomodulatory effects on the colon of mice that spontaneously develop colitis. PLoS One. 2016;11(5):e0154823.
- Detzel CJ, Horgan A, Henderson AL, Petschow BW, Warner CD, Maas KJ, Weaver EM. Bovine immunoglobulin/protein isolate binds pro-inflammatory bacterial compounds and prevents immune activation in an intestinal co-culture model. PLoS One. 2015;10(4):e0120278.
- EnteraGam® [product information]. Ankeny, IA: Entera Health, Inc.; October 2020.
- 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.
- Xifaxan® [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc.; May 2015.
- 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.
- Sartor RB, Mazmanian SK. Intestinal microbes in inflammatory bowel diseases. Am J Gastroenterol Suppl. 2012;1(1):15-21.
- Morgan SL, Baggott JE. Medical foods: products for the management of chronic diseases. Nutr Rev. 2006;64(11):495-501.
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 supervising 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 .
To report suspected adverse reactions, contact Entera Health, LLC 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.
EnteraGam® is manufactured and
distributed by Proliant Health & Biologicals, LLC.
©2023 Proliant Health & Biologicals, LLC.
Ankeny, IA 50021
ENT100P0121 01/22
The product information provided in this site is intended for residents of the United States.