Frequently Asked Questions
The Frequently Asked Questions (FAQs) below answer some of the most commonly asked questions patients have. Please check this section if you have questions, and click on the links below to learn more about IBgard®.
IBS is a frustrating, under diagnosed and undertreated condition that irritates the bowel and can disrupt the digestion of food and absorption of nutrients. It affects an estimated 15-20 percent of the U.S. population. People who have IBS often experience distressful digestive symptoms, some of which can be severe or unbearable. Abdominal pain, bloating and altered abdominal bowel habits are examples of these symptoms.
There are three major forms of IBS: IBS-M (mixed diarrhea and constipation), IBS-D (diarrhea predominant) and IBS-C (constipation predominant). The incidence of the 3 major forms of IBS has been reported as mixed diarrhea and constipation IBS-M (61.0%), diarrhea predominant IBS-D (29.3%), and constipation predominant IBS-C (9.7%). It is estimated that 90 percent of the IBS patient population is comprised of the IBS-M and IBS-D sub types.1
There is currently no cure for IBS and management options are limited, especially for IBS-M and IBS-D.
1Drossman et al. J. Clin. Gastroenterol. 2009:43(6) 541-550
Besides IBS impacting the absorption and digestion of food nutrients, the hallmark symptoms of IBS are:
- Abdominal pain or discomfort
- Abdominal bloating or distention
- Recurring diarrhea, or constipation, or a combination of both
- Urgency of bowel movement
- Passage of gas or whitish mucus in the stool
- The feeling that you have not finished a bowel movement
- Pain at bowel movement
Most doctors are not sure what causes IBS. The nerves and muscles in the bowel appear to be extra sensitive in people with IBS. Some people experience symptoms after eating. People, who suspect they have IBS, should talk to their physician.
People with IBS often suffer from diarrhea, constipation or both. These conditions reflect the movement of food through the GI tract that is either too fast or too slow. This irregular movement and other disruptions in the gut can cause poor digestion, malabsorption of nutrients and even loss of electrolytes. IBS is associated with the growth of bad bacteria and excess mucus in the gut, which can also disrupt the absorption of essential nutrients. Finally, IBS is also associated with sensitivity to certain sugars. Therefore, health care professionals often recommend restricting sugars, such as fructose, and gradually increasing fiber in the diet, starting with 2-3 grams per day. Peppermint oil has been shown to help normalize intestinal transit times 2 and thus help normalize the digestion and absorption of nutrients.
2Goerg et al, Aliment Pharmacol Ther 2003; 17: (445-451)
IBgard® helps manage the syndrome of symptoms, which include abdominal pain, bloating, diarrhea, urgency, gas/mucus, incomplete evacuation, pain at evacuation and constipation.
IBgard® is a medical food product and not a drug or dietary supplement. Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. While IBgard® does not require a prescription; it should be used under medical supervision.
IBgard® harnesses the powerful properties of l-Menthol, the principal component of peppermint oil, and delivers it quickly and reliably to the small intestine where it is needed most, via a patented breakthrough technology called SST® (Site Specific Targeting) technology. IBgard® is specially formulated for the dietary management of IBS and is the first- product using SST® (Site Specific Targeting) technology to deliver individually triple-coated, sustained release microspheres of an ultra-purified peppermint oil quickly and reliably to the small intestine where its powerful properties are needed the most in managing IBS.
It is designed to work fast. It is developed as tiny, triple-coated microspheres that move through the pylorus (the opening between the stomach and small intestine) quickly because the microspheres are less than 2mm in diameter. Therefore, these tiny microspheres do not rely on gastric emptying. Also, the microspheres have been formulated with a non-muco adhesive coating to limit their sticking to the wall of the stomach or to food particles.
l-Menthol can help to enhance nutrient absorption through the intestinal walls, making it well suited for the management of IBS. Peppermint oil has also been shown to help normalize intestinal transit times 3 - thus helping normalize nutrient absorption.
IBgard® is the first product to use SST® (Site Specific Targeting) technology, a new, patented technology developed by IM Health Science®, to deliver individually triple-coated, sustained-release microspheres of Ultramen®, an ultra-purified peppermint oil within the small intestine.
To begin, you must see your doctor for the appropriate management of your condition. Peppermint oil use in digestive health has been embedded for centuries in many civilizations including ancient Greece, Egypt and Rome, (ref: 2015 BNJ Kearns et. al).
Peppermint oil as a food extract of an everyday food, (peppermint), contains an important bioactive component, l-Menthol. L-Menthol, as a component of peppermint oil, or as an extract of peppermint oil, has medical uses in helping manage digestive conditions, including IBS. These digestive conditions are characterized by symptoms, and peppermint oil’s or l-Menthol’s bioactive nature helps manage these conditions, as evidenced by the reduction of those symptoms.
Like all medical food products, IBgard® does not require pre-approval by the FDA for marketing; however, it must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. However, even food products can be unsafe if used improperly. IBgard® is a medical food and must contain ingredients that are Generally Recognized as Safe (GRAS) or are approved food additives. IBgard® is manufactured under Good Manufacturing Practices with no added: fat, sugar, salt, starch, yeast, wheat, gluten, corn, lactose, egg, soy, peanuts, shellfish or preservatives. As with many food extracts, peppermint oil can cause allergic reactions in rare cases.
A medical food is a product regulated by law. It is often placed on the spectrum between a food and a drug. A medical food is used in the dietary management of a disease. It is required to be used under medical supervision. It is allowed to be sold as a non-prescription product.
A dietary supplement is an entity regulated by law. Dietary supplements can make what is called structure/ function claims. The products are intended to maintain health and wellness in a healthy population. Dietary supplements cannot make disease or treatment claims. Supplements, like medical foods, are available as non-prescription products.
A drug and its claim structure are approved by the FDA based on safety and efficacy. A drug is usually sold as a prescription product.
Source: FDA. Available on this site.
Doctors use guidelines and their own experience in deciding how to proceed. In the vast majority of patients, an organic cause is not found. Below is a list of organic causes the doctor may test for to exclude from his or her diagnosis:
- Bowel obstructions
- Intestinal parasites
- Bacterial infections and SIBO
- Food allergies & intolerances
- Inflammatory bowel diseases (Crohn’s and Ulcerative Colitis)
- Celiac (a genetic, autoimmune disorder resulting in gluten intolerance)
- Gallstones & Idiopathic Bile Acid Malabsorption
- Colon, carcinoid, medullary
- Ovarian cancer
IBgard® should be taken as directed by your physician. The usual adult dosage is 1-2 capsules, as needed, up to three times a day. IBgard® should be taken at least 30 minutes before or after food, with water. Dosage should not exceed eight capsules per day. IBgard® capsules may be swallowed whole – not chewed. Alternatively, the contents of the capsule may be mixed with or sprinkled on applesauce and then ingested.
IBgard® sachets (institutional packs) are available and should be administered by a healthcare provider as suggested by the labeling provided with the sachets. Sachets should be administered through a nasogastric tube or a gastrostomy tube.
IBgard® should be taken as directed by a physician. Like many other medical food products, there is no chronic use data available.
A physician should be consulted to determine if IBgard® is appropriate for use in children under 15 years of age.
IBgard® has been developed to be free of gluten and lactose.
You should never crush or chew the IBgard® capsule. If you have difficulty swallowing, then you can mix the contents of the capsule with applesauce.
Patients might experience a mild tingling sensation in the gut within 30 minutes to an hour of taking IBgard®. This mild tingling sensation should subside in about an hour. IBgard® is designed to release the trapped gas in the gut and as a result, patients may taste a peppermint oil flavor when they burp out the trapped gas. These are not unusual experiences and indicate that the product is working.
Patients should consult with their physicians before taking IBgard® with or without other products. IBgard® may interact with certain medications such as cyclosporine’s, affecting how quickly the body can break them down and increasing side effects.
IBgard® is available as capsules and as an institutional pack (sachets). In some cases, when there is difficulty swallowing whole capsules, IBgard® capsules can be opened and the contents sprinkled on applesauce. As is desirable for all medical foods, an institutional pack is available primarily for nasogastric tube or gastronomy tube administration in a hospital setting.
Like all medical foods regulated under the Orphan Drug Act Amendments of 1988 in section 5 (360ee (b) (3)), IBgard® should be given to patients receiving active medical supervision for their IBS. Physicians can provide a management plan for a patient’s IBS and instructions for use of IBgard®.
IBgard is available in the digestive aisle at CVS and Walgreens. You can also order online at www.IBgard.com or by calling 1-855- GUT-GARD.
Each IBgard® capsule contains 90mgs of ultra-purified peppermint oil. Other ingredients are microcrystalline cellulose, gelatin, methacrylic acid copolymer, hypromellose, methycellulose, triethyl citrate, polysorbate 80, FD&C Yellow#5 and FD&C Green#3. IBgard® is manufactured under Good Manufacturing Practices with no added: fat, sugar, salt, starch, yeast, wheat, gluten, corn, lactose, egg, soy, peanuts, shellfish or preservatives.
Peppermint oil has been shown to help:
- Normalize the digestion of food and absorption of nutrients, which have been compromised by IBS.
- Reduce the accompanying and often distressing symptoms of IBS including abdominal pain, bloating, diarrhea, diarrhea interrupted by constipation, urgency, gas, pain at evacuation and a sense of incomplete evacuation.
- Promote bacterial balance in the small intestine (part of the lower gut).
IBgard® is the first and only IBS product developed as tiny beads in a solid form. IBgard is specially engineered via its SST® (Site Specific Targeting) technology to enable these beads to be delivered quickly and reliably where it is needed most — predominantly in the small intestine. It has low or no potential for heartburn or anal burning that’s associated with other older generation peppermint oil products. IBgard® is also the only peppermint oil product that has been designed to be taken 30 minutes before or after eating. Only IBgard® has been shown to start working in as early as 24 hours 4.
4IBSREST, data on file IM HealthScience
IBgard® is not generally covered by health insurance. In the marketplace, patients welcome the efficacy, the relative low out-of-pocket cost, the freedom from insurance company bureaucracy and the good tolerability profile. Marketplace satisfaction is running over 80%*.
Patients should consult their medical plan to find out whether medical foods, such as IBgard® are reimbursable through FSAs. Some plans have been known to provide reimbursement for medical foods based on physician requests.