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. In a 2016 peer-reviewed and published clinical study, IBgard has been shown to start working in as early as 24 hours.§ IBgard showed efficacy in 1-2 hours, in a real-world patient-reported outcomes trial, IBSACTTM, published in a peer-reviewed journal.§

IBgard can help to...

  • Normalize digestion and absorption of food nutrients that have been compromised by IBS.1
  • Manage the accompanying and often distressing group of symptoms of IBS. These include, at varying times, abdominal pain, cramping or discomfort, bloating, diarrhea, constipation, or bouts of diarrhea interrupted by constipation.2
  • Promote bacterial balance in the small intestine (part of the lower gut).3
IBgard Caplet with Microspheres

Stylized image

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.4 The l-Menthol in peppermint oil has anti-inflammatory,5 antispasmodic,6 and visceral analgesic properties.7

IBgard - A New Advance in the Dietary Management of IBS

IBgard has been specially engineered to allow sustained release of peppermint oil from microspheres, into the small intestine for optimal delivery. Each capsule contains tiny microspheres (less than 2mm) that can pass easily from the stomach to the small intestine without relying on gastric emptying (unlike the 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.

Illustration of the stomach and small intestine
microsphere_with-labels-loop

SST® (Site Specific Targeting)

IBgard utilizes breakthrough science via SST (Site Specific Targeting) technology. This technology delivers microspheres of peppermint oil, 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.

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 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 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 the small intestine, thus spreading in a "broad brush" manner over a large area and delivering prolonged action.

IBgard Advantage

Abdominal pain or discomfort in IBS patients typically occurs after meals.8,9 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 IBgard be taken 30 minutes before meals.

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 and are associated with IBS symptoms – especially pain.

IBgard is designed to minimize the potential for heartburn and anal burning,** which is known to occur with products based on older technology (single-unit, enteric coated capsules).10

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 811(or even more) IBS symptoms. These l-Menthol actions include: anti-inflammatory, antispasmodic and as a visceral analgesic.

The anti-inflammatory activity of l-Menthol has been described by several researchers.12  It should have utility in a condition where there may be reversible, low-grade inflammation, associated with gut mucosal barrier disruption and localized immune activation.4

The antispasmodic activity of l-Menthol helps calm the uncontrolled spasms in IBS via calcium-channel-mediated relaxation of smooth muscle to restore normal peristalsis,13 including the segmental contractions that can cause constipation.14

Its visceral analgesic (especially abdominal pain and cramping) properties reflect l-Menthol’s kappa opioid agonist activity to help reduce abdominal pain and cramping.14 Unlike other kappa opioid agonists that have been clinically evaluated, free l-Menthol is not detected in the plasma in subjects that have taken l-Menthol orally. It can thus be concluded that, it works locally.15

The bloating and the gas observed in IBS patients can be caused by entrapment of gas in the small intestine.16 The carminative action of l-Menthol is helpful to control bloating.17

It is now known that the microbiome in the small intestine is altered in IBS patients.14 The antimicrobial property of peppermint oil helps manage intestinal dysbiosis.18

It can thus be concluded that the broad spectrum bioactivity of l-Menthol is very suited for the syndrome of symptoms involved in IBS.

When ultrapure peppermint oil is assisted by targeted delivery, it can have a powerful effect on the GI tract.

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, 919 placebo-controlled clinical studies have shown peppermint oil’s efficacy in IBS. 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.20 In this study peppermint oil was shown to work in both diarrhea and constipation in IBS patients.

Click here to refer to clinical studies and data.

More Information

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

1 Cash, B., Epstein, M. and Shah, S. Patient Satisfaction with IBS Symptom Relief Using IBgard in a Randomized Clinical Trial and in the General Population. International Journal of Digestive Diseases. Vol 2, No. 2:27. 2016 http://dx.doi.org/10.4172/2472-1891.100027).

2 Drossman, Douglas A., Lin Chang, Susan Schneck, Carlar Blackman, William F. Norton, and Nancy J. Norton. 2009. “A Focus Group Assessment of Patient Perspectives on Irritable Bowel Syndrome and Illness Severity.” Digestive Diseases and Sciences 54 (7): 1532–41. doi:10.1007/s10620-009-0792-6.

3 Goerg, K.J. et al., Aliment Pharmacol Ther 2003; 17:445-451.

4 González-Castro, Ana M, Cristina Martínez, Eloísa Salvo-Romero, Marina Fortea, Cristina Pardo-Camacho, Teresa Pérez-Berezo, Carmen Alonso-Cotoner, Javier Santos, and María Vicario. 2016. “Mucosal Pathobiology and Molecular Signature of Epithelial Barrier Dysfunction in the Small Intestine in Irritable Bowel Syndrome.” Journal of Gastroenterology and Hepatology, 53–63. doi:10.1111/jgh.13417.

5 Juergens, UR, M Stober, and H Vetter. 1998. European Journal of Medical Research 3 (12): 539–45.

6 Hawthron M et al (1988): Aliment Pharmacol Ther. 2(2):101-18.

7 Liu, Boyia; Fan, Lua; Balakrishna, Shrilathaa; Sui, Aiweia; Morris, John B.b; Jordt, Sven‐Erica,* Pain: October 2013 - Volume 154 - Issue 10 - p 2169–2177. doi: 10.1016/j.pain.2013.06.043.

8 Ragnarsson, Gudmundur, and Göran Bodemar. 1998. European Journal of Gastroenterology and Hepathology 10 (5): 415–21.

9 Lucak, S., Chang, L., Halpert, A., Harris, L.; Ther Adv Gastroenterol. 2017, Vol. 10(2) 253-275. DOI: 10.1177/1756283X16663396.

10 Khanna R, MD, MacDonald, J.K. MA and Levesque, B.G. MD, MS. July 2014. Clin Gastroenterol, Vol 48, Num 6, pg 505.

11 Michael S. Epstein, Brooks D. Cash, Syed M. Shah. “Targeted delivery of peppermint oil to the small intestine provides significant improvement in the syndrome of symptoms associated with Irritable Bowel Syndrome”. For poster presentation at DDW, May 2015.

12 Juergens, UR, M Stober, and H Vetter. 1998. European Journal of Medical Research 3 (12): 539–45.

13 WJ,Snape Jr. Dig Dis 1997; 15:104-11.

14 Hawthorn, M, J Ferrante, E Luchowski, A Rutledge, XY Wei, and DJ Triggle. 1988. Alimentary Pharmacology and Therapeutics 2: 101–18.

15 Galeotti, Nicoletta, Lorenzo Di Cesare Mannelli, Gabriela Mazzanti, Alessandro Bartolini, and Carla Ghelardini. 2002. Neuroscience Letters 322 (3): 145–48. doi:10.1016/S0304-3940(01)02527-7.

16 Gelal, A, P Jacob, L Yu, and N L Benowitz. 1999. Clinical Pharmacology and Therapeutics 66 (2): 128–35. doi:10.1053/cp.1999.v66.100455001.

17 Salvioli, Beatrice, Jordi Serra, Fernando Azpiroz, Carlos Lorenzo, Santiago Aguade, Joan Castell, and Juan R. Malagelada. 2005. Gastroenterology 128 (3): 574–79. doi:10.1053/j.gastro.2004.12.047.

18 Harries, Nicola, K C James, and W K Pugh. 1977. Journal of Clinical Pharmacy and Therapeutics 2 (3). Wiley Online Library: 171–77.

19 Pimentel, Mark, et. al. Large-Scale Deep Sequencing Reveals Altered Microbial Composition in IBS, Gastroenterology and Hepatology, Fall 2013.

20 Hawrelak, Jason A., Trudi Cattley, and Stephen R. Myers. 2009. Alternative Medicine Review 14 (4): 380–84.

21 Khanna R, MD, MacDonald, J.K. MA and Levesque, B.G. MD, MS. July 2014. Clin Gastroenterol, Vol 48, Num 6, pg 505.

22 Cappello, G, M Spezzaferro, L Grossi, L Manzoli, and L Marzio. 2007. Digestive and Liver Disease 39: 530–36.

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