Managing IBS

IBgard in woman's purse

Start by consulting with a physician to discuss an IBS management program that may include IBgard. IBgard utilizes breakthrough science via SST® (Site-Specific Targeting). This SST technology provides the more distal delivery mentioned in the American College of Gastroenterology (ACG) IBS 2018 Monograph. This technology delivers microspheres of peppermint oil (in a solid state), along with fiber and amino acids (from gelatin protein), predominantly in the small intestine, where it spreads out in a “broad brush” fashion for more distal delivery i.e., delivery in the lower gut (small intestine) over a 3 to 4-hour period.1

IBgard is designed to help normalize the lining of the gut (gut mucosal barrier) and reversible, localized, often temporary, low-grade immune activation, and thus help normalize the digestion and absorption of food nutrients. IBgard may also provide support against invasion of unwelcome bacteria into the small intestine, SIBO (small intestinal bacterial overgrowth).2,3

IBgard is the only peppermint oil formulated into tiny microspheres to help deliver the product quickly and reliably to the lower gut. Besides efficacy, this SST (Site-Specific Targeting) technology minimizes the potential for heartburn and anal burning, which are common side effects among older, oil-filled delivery technologies for peppermint oil.§ The American College of Gastroenterology IBS 2018 Monograph identified heartburn as an issue in IBS4 in three separate studies.4–7 They then recommended products that deliver peppermint oil lower in the GI system, beyond the stomach, for more distal delivery. This Monograph expressed concern about older, oil-filled technologies and mentioned two separate studies where heartburn was as high as 26%.5,7 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.8

IBgard has been validated by three separate studies, all producing concordant results.

In IBSRESTTM, an important randomized, multi-centered, double-blind, placebo-controlled clinical trial, IBgard, taken on a daily and proactive basis, was shown to start working on IBS symptoms in as early as 24 hours, and this benefit grew when measured at four weeks.§ No heartburn or anal burning was seen with IBgard in this study. The study was peer-reviewed and published in a distinguished medical journal in Feb. 2016.§,9 

In IBSACTTM, a real-world patient-reported outcomes trial, published in a peer-reviewed journal, IBgard showed efficacy in 1-2 hours.§§

In IBSSU24, a study of use by an estimated 700,000 patients over a 2-year period (October 5, 2015, to September 30, 2017), IBgard has shown a remarkably low side effect profile, including no pattern of heartburn or anal burning. §§§

IBgard should be taken as directed by a physician. (Usual adult dosage††: When in flare… 2 capsules, 3 times a day, for 4 weeks.* For maintenance, i.e., daily and proactive gut-health support… 2 capsules once a day.** Take 30 to 90 minutes before meal(s), with water, daily. 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.

Like all medical foods regulated under section 5(b) the Orphan Drug Act (21 U.S.C. [360ee](b)(3)), IBgard should be given only to patients receiving active medical supervision for their IBS. A physician should provide an IBS management program and instructions for use of IBgard. Once a program is in place, be sure to follow up with a physician to monitor progress and adjust the program as 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.

The IBgard Difference

IBgard Overview

IBgard is a medical food specially formulated for the dietary management of IBS. IBgard capsules contain individually triple-coated, sustained-release microspheres of Ultramen®, an ultrapurified peppermint oil, along with fiber and amino acids (from gelatin protein). In a 2016 peer-reviewed and published clinical study,†† IBSREST (IBS Response Evaluation and Safety Trial), IBgard, taken daily and proactively 30 to 90 minutes before meals, was shown to start working in as early as 24 hours and the benefit grew at 4 weeks.†† In a real-world, patient-reported outcomes trial, IBSACTTM (IBS Adherence and Compliance Trial), published in a peer-reviewed journal, §§ IBgard showed efficacy in 1-2 hours.

IBGARD_Double_Beauty_Pass

IBgard is designed to help...

  • Normalize the digestion and absorption of food nutrients that have been compromised by IBS
  • Manage the accompanying and often distressing group of symptoms of IBS. These 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
    • Sense of an incomplete bowel movement
    • Pain during bowel movement
  • Promote bacterial balance in the small intestine.

In addition to peppermint oil, each IBgard serving of 2 capsules provides approximately 640 mg of fiber and approximately 400 mg of amino acids (from gelatin protein). These, too, are intended to help toward normalizing the lining of the gut (gut mucosal barrier) and reversible, localized, low-grade immune activation. The l-Menthol in peppermint oil has anti-inflammatory10, antispasmodic11, visceral analgesic12, carminative (anti-gas)13, and anti-bacterial2,3 properties.

IBgard Site Specific Targeting Technology Animation

The IBgard Difference - Advanced Science

Peppermint oil and its principal component, l-Menthol, have a history of effectiveness in IBS. However, until recently, its targeted delivery to the small intestine had posed a challenge. IBgard utilizes breakthrough science via SST® (Site-Specific Targeting). This SST technology provides the more distal delivery mentioned in the American College of Gastroenterology (ACG) IBS 2018 Monograph. This technology delivers microspheres of peppermint oil (in a solid state), along with fiber and amino acids (from gelatin protein), predominantly in the small intestine, where it spreads out in a “broad brush” manner for more distal delivery over a 3 to 4-hour period1.

Besides helping manage IBS symptoms, this is important because 90 to 95% of nutrient absorption occurs in the small intestine.14 IBgard helps normalize the lining of the gut (gut mucosal barrier) and reversible, localized, low-grade immune activation. This action, along with its antibacterial property against unwelcome bacteria in the small intestine, helps normalize the digestion and absorption of food nutrients.

Why Targeting the Small Intestine is So Important

The symptoms of IBS often occur within 90 minutes of meals.15 This reflects the time it takes for food to reach the small intestine. Relatively recent scientific and clinical evidence points to the small intestine as the site of the disruption in the lining of the gut (gut mucosal) barrier and where transit time can also be disrupted.16 Thus, food can move too fast or too slow, causing diarrhea, constipation or bouts of diarrhea interrupted by constipation. This is also the site where abdominal pain originates, probably from irritated nerve endings in the gut or from trapped gas. Only IBgard utilizes SST® (Site-Specific Targeting) technology to deliver its ingredients to the small intestine and then enable the microspheres to spread out in a more distal delivery, "broad brush" manner, in the lower gut. IBgard has been specially formulated so that it can be taken 30 to 90 minutes before meal(s) to support the gut before it gets challenged by a meal.

1Shah S, Hassan D, Fred Hassan. ENTERIC COATED MULTIPARTICULATE CONTROLLED RELEASE PEPPERMINT OIL COMPOSITION AND RELATED METHODS - US 8,808,736 B2; Figure 2. 2014.

2Jeyakumar E, Lawrence R, Pal T. Comparative evaluation in the efficacy of peppermint (Mentha piperita) oil with standards antibiotics against selected bacterial pathogens. Asian Pac J Trop Biomed. 2011;1(SUPPL. 2). doi:10.1016/S2221-1691(11)60165-2.

3İşcan G, Ki̇ri̇mer N, Kürkcüoǧlu M, Hüsnü Can Başer, Demi̇rci̇ F. Antimicrobial Screening of Mentha piperita Essential Oils. J Agric Food Chem. 2002;50(14):3943-3946. doi:10.1021/jf011476k.

4Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology Monograph on the Management of Irritable Bowel Syndrome and Chronic Idiopathic Constipation. Am J Gastroenterol. 2018:S2-S26. doi:10.1038/ajg.2014.187.

5Khanna R, MacDonald JK, Levesque BG. Peppermint Oil for the Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2014;48(6):505-512. doi:10.1097/MCG.0b013e3182a88357.

6Merat S, Khalili S, Mostajabi P, Ghorbani A, Ansari R, Malekzadeh R. The effect of enteric-coated, delayed-release peppermint oil on irritable bowel syndrome. Dig Dis Sci. 2010;55(5):1385-1390. doi:10.1007/s10620-009-0854-9.

7Mosaffa-Jahromi M, Lankarani KB, Pasalar M, Afsharypuor S, Tamaddon AM. Efficacy and safety of enteric coated capsules of anise oil to treat irritable bowel syndrome. J Ethnopharmacol. 2016;194(November):937-946. doi:10.1016/j.jep.2016.10.083.

8Lovell RM, Ford AC. Prevalence of gastro-esophageal reflux-type symptoms in individuals with irritable bowel syndrome in the community: A meta-analysis. Am J Gastroenterol. 2012;107(12):1793-1801. doi:10.1038/ajg.2012.336.

9Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Dig Dis Sci. 2016;61(2):560-571. doi:10.1007/s10620-015-3858-7.

10Juergens U, Stober M, Vetter H. The anti-inflammatory activity of L-menthol compared to mint oil in human monocytes in vitro: a novel perspective for its therapeutic use in inflammatory diseases. Eur J Med Res. 1998;3(12):539-545.

11Hawthorn M, Ferrante J, Luchowski E, Rutledge A, Wei X, Triggle D. The actions of peppermint oil and menthol on calcium channel dependent processes in intestinal, neuronal and cardiac preparations. Aliment Pharmacol Ther. 1988;2:101-118.

12Liu B, Fan L, Balakrishna S, Sui A, Moris JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177. doi:10.1016/j.pain.2013.06.043.TRPM8.

13Harries N, James KC, Pugh WK. Antifoaming and carminative (anti-gas) actions of volatile oils. J Clin Pharm Ther. 1977;2(3):171-177.

14Dr. Ananya Mandal MD. What Does the Small Intestine Do? https://www.news-medical.net/health/What-Does-the-Small-Intestine-Do.aspx.

15Ragnarsson G, Bodemar G. Pain is temporally related to eating but not to defaecation in the irritable bowel syndrome (IBS): Patients’ description of diarrhoea, constipation and symptom variation during a prospective 6-week study. Eur J Gastroenterol Hepathology. 1998;10(5):415-421.

16González-Castro AM, Martínez C, Salvo-Romero E, et al. Mucosal pathobiology and molecular signature of epithelial barrier dysfunction in the small intestine in Irritable Bowel Syndrome. J Gastroenterol Hepatol. 2017;32:53-63. doi:10.1111/jgh.13417.

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