HEALTHCARE PROFESSIONALS

About IBgard®

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. This design enables fast access to the small intestine where there then is an initial fast release of peppermint oil from the outer part of the inner, sustained-release microsphere cores. These cores then go on to form individual hydrogels. Finally, more distal delivery continues as the remaining fiber-embedded peppermint oil from these hydrogels is released over 3 to 4 hours in the entire small intestine.

IBGARD_Double_Beauty_Pass

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In a 2016 peer-reviewed and published, randomized control trial (RCT), 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 positive effect kept expanding at the 4-week measurement point. In a real-world, patient-reported outcomes trial, IBSACTTM (IBS Adherence and Compliance Trial), published in a peer-reviewed journal § §, IBgard showed efficacy as early as 1 to 2 hours. In IBSSU24 (IBS Safety Update at 24 months), a 2-year post-marketing safety study from October 5, 2015, to September 30, 2017, no pattern of AEs (Adverse Events) was observed. § § §  Heartburn, a common issue with older, liquid-filled peppermint oils was largely avoided in the case of IBgard.

IBgard is intended to help...

  • Normalize 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, cramping or discomfort, bloating, diarrhea, constipation, or bouts of diarrhea interrupted by constipation.1
  • Promote bacterial balance in the small intestine (part of the lower gut, beyond the stomach).

 

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 the reversible, localized, often temporary, low-grade immune activation. The l-Menthol in peppermint oil has anti-inflammatory2, antispasmodic3, and visceral analgesic4 properties. Additionally, its carminative (anti-gas)5 and antibacterial6,7 properties help with bloating and other issues arising from gas and SIBO.

IBgard - A New Advance in the
Dietary Management of IBS

Illustration of the stomach and small intestineIBgard has been specially engineered to allow peppermint oil in sustained-release, solid-state microspheres to be delivered rapidly to the small intestine as more distal delivery. Once in the small intestine, there is first, a fast, initial release of peppermint oil from the outer part of the inner core, followed by a more sustained release for 3 to 4 hours over a broad area. Each capsule contains tiny microspheres (less than 2 mm) that can pass easily from the stomach to the small intestine without relying on gastric emptying (unlike older technologies that use single-unit, liquid filled capsules). Instead, these solid-state microspheres are designed to move expeditiously through the pylorus to the site of disturbance – the small intestine. Subsequently, they are designed to deliver “broad brush,” more distal release, over a 3 to 4 hour period.8

Microsphere labeled video

Specially Formulated for More Distal Delivery

SST® (Site-Specific Targeting)

IBgard utilizes breakthrough science via SST (Site-Specific Targeting) technology. This SST technology enables the more distal delivery mentioned in the American College of Gastroenterology (ACG) IBS 2018 Monograph, where heartburn was raised as a concern with older "burst technology," oil-filled capsules. SST technology delivers microspheres of peppermint oil (PO), 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 - and then spread in a “broad brush” manner to enable more distal delivery over 3 to 4 hours.8

Never before has peppermint oil been formulated into individually enteric-coated microspheres delivered to the small intestine. Each microsphere in an IBgard capsule has three layers of coating, enclosing a sustained-release, solid-state inner core. These microspheres are specially designed for travel through the various sections of the GI tract.

  • The outermost layer is non-mucoadhesive. This allows the microspheres to travel easily through the esophagus and prevents their mucoadhesion to the stomach wall and to large food particles.
  • The middle layer contains a pH-triggered coating that should not dissolve until it passes the pylorus.
  • The innermost layer preserves the peppermint oil matrix in the core until the pH trigger occurs in the small intestine.
  • The inner core of the microspheres contains a fiber matrix that entraps peppermint oil in a solid state and enables the sustained release of peppermint oil in a "broad brush" manner to complete the last phase of more distal delivery. This enables delivery to the entire small intestine over 3 to 4 hours.

The IBgard Advantage

Abdominal pain or discomfort in IBS patients typically occurs after meals.9,10 IBgard has been specially formulated so that patients can have dosing flexibility by taking it before or after meals. Since food is a primary IBS trigger, physicians are now recommending that IBgard be taken 30 to 90 minutes before a meal(s).

The SST microspheres in IBgard are designed to move quickly and reliably from the stomach to the small intestine, even if there is some food in the stomach. This allows for the rapid normalization of the maldigestion and malabsorption that have been disrupted by food intake along with the associated with IBS symptoms – especially pain.

IBgard, with its more distal delivery, is designed to minimize the potential for heartburn § § § that is known to occur with products based on older, “burst release” technology (single-unit, oil-filled, enteric-coated capsules).11,12 Anal burning, another side effect of older technologies13, is also avoided.

Introducing Scientifically Advanced Ultramen

IBgard uses Ultramen, an ultra-purified peppermint oil specially prepared under tight specifications for l-Menthol content to enable consistent and reliable efficacy and tolerability.

The Properties of Peppermint Oil

The primary component of peppermint oil is l-Menthol.

The broad spectrum bioactive benefits of l-Menthol are very suitable for a syndrome of up to 81 (or even more) IBS symptoms including the signature IBS symptom: abdominal pain or discomfort. These l-Menthol actions include: anti-inflammatory, antispasmodic, visceral analgesic, carminative (anti-gas) and antibacterial.

The anti-inflammatory activity of l-Menthol has been described by several researchers.2,14 It should have utility in a condition where there may be reversible, often temporary, low-grade inflammation associated with gut mucosal barrier disruption and localized immune activation.

The strong efficacy data in both IBSREST and IBSACT indicate that all of IBgard’s properties help toward achieving equilibrium (homeostasis). For maintaining homeostasis, a combination of daily and proactive biopsychosocial practices, as well as taking a gut-calming agent, like IBgard, before a meal(s), can help avoid the severity and frequency of future IBS flares.

The following is a more detailed explanation of IBgard’s properties.

The antispasmodic activity of l-Menthol, via calcium-channel-mediated relaxation of smooth muscle, helps calm the uncontrolled spasms in IBS, including the segmental contractions that can cause constipation, to restore normal peristalsis.3,15

Its visceral analgesic properties (especially to fight or prevent abdominal pain and cramping) reflect l-Menthol’s kappa opioid agonist activity to help reduce abdominal pain and cramping.4 Unlike other kappa opioid agonists that have been clinically evaluated, free l-Menthol is not detected in the plasma in subjects who have taken l-Menthol orally. It can thus be concluded that it works locally.16

The bloating and the gas observed in IBS patients can be caused by the entrapment of gas in the small intestine.17,18 The carminative (anti-gas) action of l-Menthol is helpful to control bloating.5

It is now clearly established that the microbiome in the small intestine is often altered in IBS patients.19 The antimicrobial, including antibacterial, property of peppermint oil may help manage intestinal dysbiosis.6,7

When ultrapure peppermint oil is assisted by targeted delivery, it can have a powerful and targeted effect on the GI tract. It thus can be concluded that the broad-spectrum bioactivity of l-Menthol is very well-suited for the gut disruption issues and the syndrome of symptoms involved in IBS.

Peppermint Oil is a Well-Studied Ingredient

Beyond its well-established mode of action, peppermint oil’s (and l-Menthol’s) efficacy in IBS has been clearly established.

Since 1979, seven placebo-controlled clinical studies have shown peppermint oil’s efficacy in IBS.20 In one clinical study, 75% of patients treated with peppermint oil experienced a >50% reduction in total IBS symptoms compared to placebo. Efficacy was maintained after a 4-week wash out period.15 In this study, peppermint oil was shown to work in both diarrhea and constipation in IBS patients.

IBgard Stands Alone

Based on the American College of Gastroenterology (ACG) IBS 2018 Monograph, more distal delivery products can help avoid the heartburn which is associated with older technologies.20 IBgard’s SST technology meets this more distal delivery criteria. Among peppermint oils, IBgard stands alone.

 

Click here to refer to clinical studies and data.

More Information

For more information, please visit Frequently Asked Questions about IBgard.

1Cash 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.

2Juergens 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.

3Hawthorn 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.

4Liu 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.

5Harries N, James KC, Pugh WK. Antifoaming and carminative (anti-gas) actions of volatile oils. J Clin Pharm Ther. 1977;2(3):171-177.

6İşcan 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.

7Jeyakumar 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.

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

9Ragnarsson 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.

10ucak S, Chang L, Halpert A, Harris LA. Current and emergent pharmacologic treatments for irritable bowel syndrome with diarrhea: evidence-based treatment in practice. Therap Adv Gastroenterol. 2017;10(2):253-275. doi:10.1177/1756283X16663396.

11Khanna 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.

12Mosaffa-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.

13Liu J-H, Chen G-H, Yeh H-Z, Huang C-K, Poon S-K. Enteric-coated peppermint-oil capsules in the treatment of irritable bowel syndrome: A prospective, randomized trial. J Gastroenterol. 1997;32(6):765-768. doi:10.1007/BF02936952.

14Liu Z, Shen C, Tao Y, et al. Chemopreventive efficacy of menthol on carcinogen-induced cutaneous carcinoma through inhibition of inflammation and oxidative stress in mice. Food Chem Toxicol. 2015;82:12-18. doi:10.1016/j.fct.2015.04.025.

15Cappello G, Spezzaferro M, Grossi L, Manzoli L, Marzio L. Peppermint oil (Mintoil) in the treatment of irritable bowel syndrome: A prospective double blind placebo-controlled randomized trial. Dig Liver Dis. 2007;39:530-536.

16Galeotti N, Di Cesare Mannelli L, Mazzanti G, Bartolini A, Ghelardini C. Menthol: a natural analgesic compound. Neurosci Lett. 2002;322(3):145-148. doi:10.1016/S0304-3940(01)02527-7.

17Azpiroz F, Malagelada J-R. Abdominal Bloating. Gastroenterology. 2005;129:1060-1078. doi:10.1053/j.gastro.2005.06.062.

18Salvioli B, Serra J, Azpiroz F, et al. Origin of gas retention and symptoms in patients with bloating. Gastroenterology. 2005;128(3):574-579. doi:10.1053/j.gastro.2004.12.047.

19Collins SM. A role for the gut microbiota in IBS. Nat Rev Gastroenterol &Amp; Hepatol. 2014;11:497.

20Ford 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.

 

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