Frequently Asked Questions for Healthcare Professionals
People who have IBS experience, at various times, distressing digestive symptoms including the signature symptoms of abdominal pain, discomfort or cramping, often accompanied by bloating, gas, diarrhea, constipation or bouts of diarrhea interrupted by constipation, urgency of bowel movement, the sense of an incomplete bowel movement, and pain during a bowel movement. Some of these symptoms can be severe or unbearable.
IBS is the second leading cause of absenteeism, after the common cold.1 It is a common disorder, affecting an estimated 10-15 percent of the U.S. population2, in which the bowel is irritated and does not function properly. Only 25%2 of IBS patients seek medical help and are diagnosed – and their IBS is often undermanaged. This frustrating condition should be taken seriously, as it can affect the digestion and absorption of food nutrients.
IBS for individual patients can be a multi-year journey of symptoms that may remit and then relapse or persist on a steady basis. The symptoms may change at different times.
Measures to manage IBS on a daily and proactive basis can help reduce the frustration felt by many IBS patients in their multi-year journeys with IBS.
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 these three major forms o has been reported as IBS-M - 61.0%, IBS-D - 29.3%, and IBS-C -9.7%. It is estimated that 90 percent of the IBS patient population is comprised of the IBS-M and IBS-D subtypes.3
More recently, a fourth type of IBS, described as IBS-U (IBS un-subtyped), has gained visibility.4 It is often defined as pain-predominant IBS with less than 25% incidence of diarrhea or constipation.
While progress in scientific and medical knowledge of IBS and in new products to manage IBS has been made during the past 10 years, management options remain limited, especially for IBS-M and IBS-U.
In addition to impacting the digestion and absorption of food nutrients, the syndrome of symptomsTM of IBS can include, at varying times, some or all of the following:*
- Abdominal pain, discomfort, or cramping
- Bloating or gas
- Diarrhea, constipation, or bouts of diarrhea interrupted by constipation
- Urgency of bowel movement
- The sense of an incomplete bowel movement
- Pain during bowel movement
IBS symptoms can usually be sensed below the navel, in the belly.
IBS can be triggered by food, stress, environment, infections, and genetic predisposition.5
In the absence of a known organic cause, it is thought that IBS is associated with the disruption in the lining of the gut (gut mucosal barrier) and reversible, localized, often temporary, low-grade immune activation6 in the gut. Another factor for IBS is the invasion and growth of unwelcome bacteria into the small intestine, called small intestinal bacterial overgrowth (SIBO). These unwelcome bacteria compete with intestinal cells for nutrients and give off gases such as hydrogen and methane as they consume nutrients. These extra gases add to IBS-related bloating. SIBO also adds to the gut mucosal barrier disruption by creating extra maldigestion and extra malabsorption. The reversible, localized, often temporary, low-grade inflammation, and altered permeability in the gut results in an impaired ability to digest and absorb food nutrients. Intestinal malabsorption triggers IBS symptoms, often after a meal. If IBS is suspected, consult with a physician about confirming IBS and then developing a program to manage it.3
IBgard® helps manage the syndrome of symptomsTM, which, at varying times, includes some or all of the following*: abdominal pain, discomfort or cramping, bloating or gas, diarrhea, constipation or bouts of diarrhea interrupted by constipation, urgency of bowel movement, the sense of an incomplete bowel movement, and pain during a bowel movement.
IBgard should be taken as directed by a physician. Usual adult dosage††:
For daily and proactive gut-health support: Two capsules once a day. Take 30 to 90 minutes before a meal, with water.***
When in flare: Two capsules, three times a day, for four weeks. Take 30 to 90 minutes before meals, with water.*
Do not exceed eight capsules per day. Swallow capsules whole or mix microspheres with applesauce. Do not chew.
IBgard sachets (institutional packs) should be administered by a healthcare provider through a nasogastric or gastrostomy tube.
If pre-meal dose is missed, IBgard can be taken when needed.
††Note: These directions reflect a slight change, to allow for separate “in flare” and “daily and proactive gut-health support” and also to recommend 30 to 90 minutes pre-meal dosing, to allow time for the gut lining to be better supported before it is challenged by meal(s).
*Based primarily on IBSREST (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). Physicians may customize based on a patient’s individual situation.
**Based primarily on IBSACT (IBS Adherence and Compliance Trial). Physicians may customize based on a patient’s individual situation.
Patients should consult with a physician before taking IBgard with or without other products. Peppermint oil is a well-characterized food extract. It belongs to a group of natural source terpenes that may interact with certain medications such as cyclosporine, affecting how quickly the body can break them down. As with all food extracts, in rare cases, there may be a sensitivity or allergic reactions.
In IBSSU24 (IBS Safety Update at 24 months), a two-year, real-world study in over 700,000 patients (from October 5, 2015, to September 30, 2017), no pattern of adverse events with IBgard was observed§§§.
Many physicians add IBgard to their patients’ prescriptions, often to let IBgard’s early visceral analgesic, anti-inflammatory and antispasmodic effects help improve the chances of patients filling their prescriptions and then adhering to them. Other physicians may start with IBgard first.
Can “side effects” such as diarrhea or constipation or abdominal pain or discomfort or cramping or heartburn or nausea be possibly seen with IBgard?
These kinds of symptoms are hard to separate from pre-existing gastrointestinal conditions that may also be present with the same symptoms. In a FGID (Functional Gastrointestinal Disorder) such as IBS, there can be a broad range of symptoms which may occur at varying times, and with varying intensities, and which may overlap with perceived “side effects” from taking IBgard for IBS symptoms. In a real-world post-marketing safety assessment (IBSSU36)a, no distinct pattern of side effects emerged with IBgard in an estimated user population of 2.4 million. While IBgard continues to provide a reassuring profile of safety and tolerability, if one suspects a side effect or an interaction with a food, drug or a supplement, one should stop taking IBgard and discuss the condition again with a physician.
Among the older peppermint oil products which do not have the more distal delivery feature that is present in IBgard, heartburn as a side effect has been noted b,c,d. It has also been noted that heartburn is present at four times the level in an IBS population than in the general population e. So a more distal delivery peppermint oil product is preferred.
IBgard harnesses the broad-spectrum properties of l-Menthol, the principal component of ultrapurified peppermint oil (PO). IBgard utilizes breakthrough science via SST® (Site-Specific Targeting). This technology delivers microspheres of peppermint oil (in a solid state), along with fiber and amino acids (from gelatin protein), quickly and reliably where they are needed the most in IBS – predominantly in the small intestine. This SST technology is designed for more distal delivery. This means rapid transit through the stomach to the small intestine, followed by "broad brush" delivery to the entire small intestine over 3 to 4 hours after the initial pH-triggered release in the small intestine. This is important, as 90% to 95% of nutrient absorption occurs in the small intestine.7
IBgard is designed to work fast. It is developed as tiny, triple-coated, solid-state microspheres that move through the pylorus (the opening/filter between the stomach and small intestine) quickly because the microspheres are less than 2 mm in diameter. Therefore, these tiny microspheres do not rely on gastric emptying. Also, the microspheres have been formulated with a non-mucoadhesive coating to limit their sticking to the wall of the stomach or to food particles. Once it's rapidly transited through the stomach and released in the small intestine, the microspheres continue to provide more distal delivery by
- first, releasing PO fast from only the outer part of the uncoated inner core of the solid-state PO microspheres as soon as this outer part is in contact with the moist environment in the small intestine
- and second, releasing PO slowly, as the inner core microspheres spread out in a “broad brush” manner, form dispersed and uncoated hydrogels with individual concentration gradients, and release the remaining PO over 3 to 4 hours.
This more distal delivery was identified in the American College of Gastroenterology (ACG) IBS 2018 Monograph as the preferred release system for peppermint oil, especially to avoid heartburn.8 This Monograph expressed concern about older, oil-filled technologies and mentioned two separate studies where heartburn was as high as 26%.9,10 The ACG IBS 2018 Monograph went on to state that "...there could be an issue in an IBS subject, given the frequent occurrence of this symptom (heartburn) in the IBS sufferer." And, in an IBS population, the Monograph pointed out that reflux-type symptoms were already four times as high as the non-IBS population.11
L-Menthol has anti-inflammatory12, antispasmodic13, visceral analgesic14, carminative (anti-gas)15 and antibacterial properties.16,17 L-Menthol can help enhance nutrient absorption through the intestinal walls18, making it well suited for the management of IBS. Peppermint oil has also been shown to help normalize intestinal transit times19, thus helping to further normalize nutrient absorption.
IBgard is the first product to use SST (Site-Specific Targeting), a new, patented technology developed by IM HealthScience.® SST delivers individually triple-coated, sustained-release microspheres of Ultramen®, an ultrapurified peppermint oil, along with fiber and amino acids (from gelatin protein), quickly and reliably to the small intestine and enables more distal delivery as described earlier in this answer.