EnteraGam is a Powerful Product!

EnteraGam is a medical food treatment that I read about in an article about IBS in Prevention magazine.

http://enteragam.com/

EnteraGam contains immunoglobulins that can boost immunity in your gut and has clinical trials that show that it has positive effects on IBS and IBD. It is a natural product, a food, and not a drug and has no drug side effects. Sounds great, yeah? Well,...

There is a definite ick factor, however. This product is actually made from raw cow blood. I had quite a few questions for the company that I needed answered before I would ever consider using this product! Below is a consolidation of an email exchange that took place with Tim Bradshaw of EnterGam. My questions are in bold.

Thank you for your excellent questions regarding EnteraGam. I’ll try to answer to the extent possible and hope this information helps you. You may also want to visit our website at: www.enteragam.com

Is EnteraGam a raw product or is it sanitized?
EnteraGam is not a raw product; it is manufactured in a GMP facility from USDA edible grade plasma collected under rigorous controls from cattle. It undergoes extensive safety analysis, including tests looking for pathogenic bacteria, before packaging. Because it is taken orally it does not need to be sterilized.

Why does it need to be supervised by a physician?
The FDA requires that all Medical Foods are used under medical supervision.

Does this product cause any negative reactions?
While the safety of EnteraGam is well-documented, like any other substance introduced into the body, whether it be a drug or foods that one eats, side effects can sometimes occur. The side effects most frequently reported for EnteraGam include abdominal cramps, constipation, diarrhea, headache, and nausea. When these occur they are typical mild to moderate in intensity.

Can EnteraGam cause detoxification symptoms from healing the gut?
To the knowledge, we have not received reports of detoxification symptoms appearing in patients using EnteraGam.

Does this product make people feel a little worse before they feel better?
We have had some patients in the first week feel a bit worse. It seems to be transient and if they stick with the product, they feel much better the week after.

Is the product heated above 165 degrees F? Or is it just checked for pathogens? I understand that this product is made from blood, and all kinds of things can be present in that. I'm trying to understand how safe it is.
EnteraGam is an exceptionally safe product – in fact it has what is called GRAS (generally recognized as safe) status with the FDA. In addition to the testing of the final product, there are numerous steps in the manufacturing process that ensure no pathogens are present. You cannot heat sterilize a protein product as that would destroy the structure, and thus, activity of the immunoglobulins that are present. Over 3 million doses of EnteraGam have been taken by patients so its track record for safety is well established.

What specific aspects will the doctor be supervising? Is there something dangerous about the product that doctors need to watch for?
Medical supervision is required for all medical foods and your physician should always be monitoring your health status. Also, if you were to experience some mild constipation, you would want to contact him / her for a possible reduction in dose.

Does this product boost the immune system or directly kill bacteria or cause the body to respond to pathogenic bacteria in the gut?
EnteraGam does not kill bacteria – that would make it an antibiotic. While not really an “immune modulator” it does support the immune system by binding to breakdown products from bacteria and viruses in the GI tract that, left unchecked, can cross the epithelial lining of the intestine and cause inflammation and other problems.

Does this product act like bovine colostrum in that is has immunoglobulins?It is similar to bovine colostrum but more potent due to the higher concentration of immunoglobulins present.

Please tell me if EnteraGam is filtered to remove viruses and any other type of pathogen. If possible, please explain or send me a link to information about the filtration technique used, so I can understand how safe this product is. I will appreciate detailed, technical information.
Pathogen removal is achieved by a variety of steps in the manufacturing process, but not by filtration as that would also remove the protein, and thus, immunoglobulin content. The product is then tested for viruses and microbes before packaging. I’m afraid that our manufacturing process is proprietary so I cannot provide a link where you can find details.

I read that Enteragam is not absorbed until the large intestine. I have Crohn's disease of the small intestine. Can Enteragam have any effect on the small intestine? After it is absorbed in the large intestine, does it have systemic affects that could possibly help with my small intestine problems?
The immunoglobulins in EnteraGam are not absorbed intact into the bloodstream; they are first digested into much smaller peptides and individual amino acids. Our studies support others demonstrating that a significant amount (40-50%, if I recall correctly) survives past the stomach before entering the small intestine. Over the last several years we’ve collected significant data on the efficacy of EnteraGam in Crohn’s disease. If you run an internet search on “serum-derived bovine immunoglobulin” and IBD, you’ll find a number of articles discussing this efficacy.

In the end, I decided to go ahead and try EnteraGam. Since I am notoriously sensitive to treatments that are capable of causing die-off reactions, I tried 1/4 teaspoon for several weeks, and I could not handle the diarrhea, nausea, headache and other typical die-off symptoms. I then tried less, but have not found a dose that I can tolerate yet.

My feeling is that this is a powerful product that might actually help me if I could actually take it. But it will be impossible or very hard for me to do so. So it is a fail for me.