HEALTHCARE PROFESSIONALS

Frequently Asked Questions

The Frequently Asked Questions (FAQs) below answer some of the more commonly asked questions patients have. Please check this section if you have questions, and click on the links below to learn more about IBgard.®

1Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: Prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005;21(11):1365-1375. doi:10.1111/j.1365-2036.2005.02463.x.

2Cash B, Sullivan S, Barghout V. Total costs of IBS: employer and managed care perspective. Am J Manag Care. 2005;11(1 Suppl):S7-16. doi:2834 [pii].

3Drossman DA, Morris CB, Schneck S, et al. International Survey of Patients with IBS: Symptom Features and their Severity, Health Status, Treatments, and Risk Taking to Achieve Clinical Benefit. J Clin Gastroenterol. 2009;43(6):541-550. doi:10.1097/MCG.0b013e318189a7f9.INTERNATIONAL.

4Rome IV: Functional Gastrointestinal Disorders, Disorders of Gut-Brain Interaction, Fourth Edition.; 2016.

5Koberstein W. Janet Woodcock - CDER, Safety, And The Cutting Edge. Life Sci Lead. 2011.

6International Foundation for Functional Gastrointestinal Disorders (IFFGD). IBS Patients: Their Illness Experience and Unmet Needs.; 2009.

7González-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.

8Cash 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.

9Ford 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.

10Dr. Ananya Mandal MD. What Does the Small Intestine Do? https://www.news-medical.net/health/What-Does-the-Small-Intestine-Do.aspx.

11Juergens 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.

12Hawthorn M, Ferrante J, Luchowski E, Rutledge A, Wei X, Triggle D. The actions of peppermint oil and menthol on calcium channel dependenf processes in in testinal, neuronal and cardiac preparations. Aliment Pharmacol Ther. 1988;2:101-118.

13Liu 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.

14Yu Q, Li P, Yang Q. Improving the absorption of earthworm fibrinolytic enzymes with mucosal enhancers. Pharm Biol. 2010;48(7):816-821. doi:10.3109/13880200903283681.

15Goerg KJ, Spilker T. Effect of peppermint oil and caraway oil on gastrointestinal motility in healthy volunteers: A pharmacodynamic study using simultaneous determination of gastric and gall-bladder emptying and orocaecal transit time. Aliment Pharmacol Ther. 2003. doi:10.1046/j.1365-2036.2003.01421.x.

16Harries N, James KC, Pugh WK. Antifoaming and carminative (anti-gas) actions of volatile oils. J Clin Pharm Ther. 1977;2(3):171-177.

17Jeyakumar 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.

18İşcan 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.

19Ford 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. 2014;109(SUPPL. 1):S2-S26. doi:10.1038/ajg.2014.187.

20Khanna 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.

21Mosaffa-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.

22Lovell 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.

23Shah S, Hassan D, Fred Hassan. ENTERIC COATED MULTIPARTICULATE CONTROLLED RELEASE PEPPERMINT OIL COMPOSITION AND RELATED METHODS - US 8,808,736 B2. 2014. doi:10.1016/j.(73).

24Shah S, Fred Hassan. ENTERIC COATED MULTIPARTICULATE COMPOSITION WITH PROTEINACEOUS SUBCOAT - US 8,895,086 B2. 2014. doi:10.1016/j.(73).

25Shah S, Fred Hassan. ENTERIC COATED MULTIPARTICULATE COMPOSITION WITH PROTEINACEOUS SUBCOAT - US 9,192,583 B2. 2015. doi:10.1016/j.(73).

26Shah S, Hassan D, Fred Hassan. ENTERIC COATED MULTIPARTICULATE CONTROLLED RELEASE PEPPERMINT OIL COMPOSITION AND RELATED METHODS - US 9,393,279 B2. 2016.

27Shah S, Hassan F. ENTERIC COATED MULTIPARTICULATE COMPOSITION WITH PROTEINACEOUS SUBCOAT - US 9,572.782 B2. 2017. doi:10.1016/j.(73).

28Shah S, Hassan D, Hassan F. ENTERC COATED MULTIPARTICULATE CONTROLLED RELEASE PEPPERMINT OL COMPOSITION AND RELATED METHODS - US 9,707,260 B2. 2017. doi:10.1016/j.(73).

29Shah S, Hassan F. ENTERIC COATED MULTIPARTICULATE COMPOSITION WITH PROTEINACEOUS COATING FOR IMPROVED STORAGE STABILITY - US 9,717,696 B2. 2017. doi:10.1016/j.(73).

30Cash BD, Epstein MS, Shah SM. Patient satisfaction with IBS symptom relief using a novel peppermint oil delivery system in a randomized clinical trial and in the general population. Int J Dig Dis. 2016;2(2):1-5

31Real-World Data From Surveillance Study Confirms Excellent Safety And Tolerability Profile Of IBgard® At 24 Months. https://www.prnewswire.com/news-releases/real-world-data-from-surveillance-study-confirms-excellent-safety-and-tolerability-profile-of-ibgard-at-24-months-300633166.html.

32Singh R, Shushni MAM, Belkheir A. Antibacterial and antioxidant activities of Mentha piperita L. Arab J Chem. 2015;8(3):322-328. doi:10.1016/j.arabjc.2011.01.019

33QuintilesIMS. Alpha ImpactRx ProVoice Survey IBgard Is the #1 Gastroenterologist Recommending Peppermint Oil For Patients with IBS.; 2016.

34QuintilesIMS. Alpha ImpactRx ProVoice Survey IBgard Is the #1 Gastroenterologist Recommending Peppermint Oil For Patients with IBS.; 2017.

35Brown K, DeCoffe D, Molcan E, Gibson DL. Diet-induced dysbiosis of the intestinal microbiota and the effects on immunity and disease. Nutrients. 2012;4(8):1095-1119. doi:10.3390/nu4081095.

36Salvioli 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.

37Serra J, Azpiroz F, Malagelada JR. Impaired transit and tolerance of intestinal gas in the irritable bowel syndrome. Gut. 2001;48(1):14-19. doi:10.1136/gut.48.1.14.

38Naliboff BD, Munakata J, Fullerton S, et al. Evidence for two distinct perceptual alterations in irritable bowel syndrome. Gut. 1997;41(4):505-512. doi:10.1136/gut.41.4.505.

39ALVAREZ WC. Hysterical type of nongaseous abdominal bloating. Arch Intern Med. 1949;84(2):217-245.

40Akiho H, Ihara E, Nakamura K. Low-grade inflammation plays a pivotal role in gastrointestinal dysfunction in irritable bowel syndrome. World J Gastrointest Pathophysiol. 2010;1(3):97. doi:10.4291/wjgp.v1.i3.97.

41Akbar A, Yiangou Y, Facer P, Walters JRF, Anand P, Ghosh S. Increased capsaicin receptor TRPV1-expressing sensory fibres in irritable bowel syndrome and their correlation with abdominal pain. Gut. 2008;57(7):923-929. doi:10.1136/gut.2007.138982.

42Liebregts T, Adam B, Bredack C, et al. Immune Activation in Patients With Irritable Bowel Syndrome. Gastroenterology. 2007;132(3):913-920. doi:10.1053/j.gastro.2007.01.046.

43Kim YS, Ho SB. Intestinal goblet cells and mucins in health and disease: Recent insights and progress. Curr Gastroenterol Rep. 2010;12(5):319-330. doi:10.1007/s11894-010-0131-2.

44Mackie AR, Macierzanka A, Aarak K, et al. Sodium alginate decreases the permeability of intestinal mucus. Food Hydrocoll. 2016;52:749-755. doi:10.1016/j.foodhyd.2015.08.004.

45Thompson A, Meah D, Ahmed N, et al. Comparison of the antibacterial activity of essential oils and extracts of medicinal and culinary herbs to investigate potential new treatments for irritable bowel syndrome. BMC Complement Altern Med. 2013;13:1-19. doi:10.1186/1472-6882-13-338.

46Grace E, Shaw C, Whelan K, Andreyev HJN. Review article: Small intestinal bacterial overgrowth - Prevalence, clinical features, current and developing diagnostic tests, and treatment. Aliment Pharmacol Ther. 2013;38(7):674-688. doi:10.1111/apt.12456.

47DiBaise J. Nutritional consequences of small intestinal bacterial overgrowth. Pract Gastroenterol. 2008;(December):15-28.

48Logan AC, Beaulne TM. The treatment of small intestinal bacterial overgrowth with enteric-coated peppermint oil: a case report. Altern Med Rev. 2002;7(5):410-417.

49Lacy BE. The Science, Evidence, and Practice of Dietary Interventions in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2015;13(11):1899-1906. doi:10.1016/j.cgh.2015.02.043.

50Parker TJ, Naylor SJ, Riordan AM, Hunter JO. Management of patients with food intolerance in irritable bowel syndrome: the development and use of an exclusion diet. J Hum Nutr Diet. 1995;8(3):159-166.

51Talley NJ, Spiller R. Irritable bowel syndrome: A little understood organic bowel disease? Lancet. 2002;360(9332):555-564. doi:10.1016/S0140-6736(02)09712-X.

52IBS Diets. FODMAP Food List. https://www.ibsdiets.org/fodmap-diet/fodmap-food-list/.

53Wahnschaffe U, Ullrich R, Riecken EO, Schulzke JD. Celiac disease-like abnormalities in a subgroup of patients with irritable bowel syndrome. Gastroenterology. 2001;121(6):1329-1338. doi:10.1053/gast.2001.29572.

54Health Union. Let’s Talk About IBS: What people with IBS want others to know. https://health-union.com/blog/lets-talk-ibs-people-ibs-want-others-know/.

55Bull MJ, Plummer NT. Part 1: The Human Gut Microbiome in Health and Disease. Integr Med (Encinitas). 2014;13(6):17-22. doi:26770121.

56Pimentel M, Lin H, Enayati P, et al. Methane, a gas produced by enteric bacteria, slows intestinal transit and augments small intestinal contractile activity. Am J Physiol Gastrointest Liver Physiol. 2006;290:G1089-G1095. doi:10.1152/ajpgi.00574.2004.

57Axe J. Do You Have SIBO Symptoms? Here Is ALL You Need to Know. https://draxe.com/sibo-symptoms/.

58Diaz R, Quevedo Sarmiento RDJ, Ramos Cormenzana A, Cabo P, Cabo J. Phytochemical and antibacterial screening of some species of Spanish Lamiaceae. Fitoterapia. 1988;59:330-334.

59Goldsmith G, Levin JS. Effect of sleep quality on symptoms of irritable bowel syndrome. Dig Dis Sci. 1993;38(10):1809-1814.

60Fritscher-Ravens A, Schuppan D, Ellrichmann M, et al. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014;147(5):1012-1020.e3. doi:10.1053/j.gastro.2014.07.046.

61Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An Evidence-based Systematic Review of the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2009;104(1):1-35. doi:10.1038/ajg.2008.122.

62Tillisch K. Complementary and alternative medicine for gastrointestinal disorders. Clin Med. 2007;7(3):224-227. doi:10.1136/gut.2005.078089.

63Ruepert L, Quartero A, de Wit N, van der Heijden G, Rubin G, Muris J. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev. 2011;8(11).

64Schoenfeld PS. Advances in IBS 2016: A Review of Current and Emerging Data. Gastroenterol Hepatol (N Y). 2016;12(8 Suppl 3):1-11.

65Su AM, Shih W, Presson AP, Chang L. Characterization of symptoms in irritable bowel syndrome with mixed bowel habit pattern. Neurogastroenterol Motil. 2014;26(1):36-45. doi:10.1111/nmo.12220

66Swift D, Bilal M. IBS Purgatory: Mixed Irritable Bowel Syndrome. AGA Read Room. 2016.

67Cash BD, Epstein MS, Shah S. Peppermint Oil with Site-Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits. Intern Med Rev. 2017;3(9):1-20.

68Cash B, Epstein M, Shah S. In Patients with Irritable Bowel Syndrome-Mixed (IBS-M), a Novel Peppermint Oil Formulation Designed for Site-Specific Targeting (PO-SST) in the Small Intestine Improves the 8 Symptoms that Comprise the Total IBS Symptoms Score (TISS). In: Digestive Disease Week. Chicago, IL; 2017.

69Cappello 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.

70Epstein M, Cash B, Shah S. Patient satisfaction with IBS symptom relief using a novel peppermint oil delivery system in a randomized clinical trial and in the general IBS patient population. In: Poster Presentation at ACG Annual Scientific Meeting, Honolulu, Hawaii. ; 2015.

71IRI Sales Data.

72Hayes PA, Fraher MH, M Quigley EM. Irritable Bowel Syndrome: The Role of Food in Pathogenesis and Management. Gastroenterol Hepatol (N Y). 2014;10(3).

73Dinan TG, Quigley EMM, Ahmed SMM, et al. Hypothalamic-pituitary-gut axis dysregulation in irritable bowel syndrome: Plasma cytokines as a potential biomarker? Gastroenterology. 2006;130(2):304-311. doi:10.1053/j.gastro.2005.11.033.

74Hughes PA, Zola H, Penttila IA, Blackshaw LA, Andrews JM, Krumbiegel D. Immune activation in irritable bowel syndrome: Can neuroimmune interactions explain symptoms. Am J Gastroenterol. 2013;108(7):1066-1074. doi:10.1038/ajg.2013.120.

75Dunlop SP, Jenkins D, Spiller RC. Distinctive clinical, psychological, and histological features of postinfective irritable bowel syndrome. Am J Gastroenterol. 2003;98(7):1578-1583. doi:10.1111/j.1572-0241.2003.07542.x.

76Martin‐Viñas JJ, Quigley EMM. Immune response in irritable bowel syndrome: A systematic review of systemic and mucosal inflammatory mediators. J Dig Dis. 2016;17(9):572-581.

77Barbara G. Mucosal barrier defects in irritable bowel syndrome. Who left the door open? Am J Gastroenterol. 2006;101(6):1295.

78Bashashati M, Rezaei N, Shafieyoun A, et al. Cytokine imbalance in irritable bowel syndrome: A systematic review and meta-analysis. Neurogastroenterol Motil. 2014;26(7):1036-1048. doi:10.1111/nmo.12358.

79Spiller R, Lam C. An update on post-infectious irritable bowel syndrome: Role of genetics, immune activation, serotonin and altered microbiome. J Neurogastroenterol Motil. 2012;18(3):258-268. doi:10.5056/jnm.2012.18.3.258.

80Foley S, Garsed K, Singh G, et al. Impaired uptake of serotonin by platelets from patients with irritable bowel syndrome correlates with duodenal immune activation. Gastroenterology. 2011;140(5):1434-1443.e1. doi:10.1053/j.gastro.2011.01.052.

81Wang H, Steeds J, Motomura Y, et al. CD4+ T cell-mediated immunological control of enterochromaffin cell hyperplasia and 5-hydroxytryptamine production in enteric infection. Gut. 2007;56(7):949-957. doi:10.1136/gut.2006.103226.

82Guilarte M, Santos J, de Torres I, et al. Diarrhoea-predominant IBS patients show mast cell activation and hyperplasia in the jejunum. Gut. 2007;56(2):203-209. doi:10.1136/gut.2006.100594.

83Wang SH, Dong L, Luo JY, et al. Decreased expression of serotonin in the jejunum and increased numbers of mast cells in the terminal ileum inpatients with irritable bowel syndrome. World J Gastroenterol. 2007;13(45):6041-6047. doi:10.3748/wjg.13.6041.

84Weston AP, Biddle WL, Bhatia PS, Miner PB. Terminal ileal mucosal mast cells in irritable bowel syndrome. Dig Dis Sci. 1993;38(9):1590-1595.

85Wang LH, Fang XC, Pan GZ. Bacillary dysentery as a causative factor of irritable bowel syndrome and its pathogenesis. Gut. 2004;53(8):1096-1101. doi:10.1136/gut.2003.021154.

86Park JH, Rhee PL, Kim HS, et al. Mucosal mast cell counts correlate with visceral hypersensitivity in patients with diarrhea predominant irritable bowel syndrome. J Gastroenterol Hepatol. 2006;21(1 PART1):71-78. doi:10.1111/j.1440-1746.2005.04143.x.

87O’Sullivan M, Clayton N, Breslin NP, et al. Increased mast cells in the irritable bowel syndrome. Neurogastroenterol Motil. 2000;12(5):449-457. doi:10.1046/j.1365-2982.2000.00221.x.

88Park CH, Joo YE, Choi SK, Rew JS, Kim SJ, Lee MC. Activated mast cells infiltrate in close proximity to enteric nerves in diarrhea-predominant irritable bowel syndrome. J Korean Med Sci. 2003;18(2):204.

89Piche T, Saint Paul MC, Dainese R, et al. Mast cell and cellularity of the colonic mucosa correlated with fatigue and depression in the irritable bowel syndrome. Gut. 2008.

90Vivinus-Nebot M, Dainese R, Anty R, et al. Combination of allergic factors can worsen diarrheic irritable bowel syndrome: role of barrier defects and mast cells. Am J Gastroenterol. 2012;107(1):75-81. doi:10.1038/ajg.2011.315.

91Barbara G, Stanghellini V, De Giorgio R, et al. Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome. Gastroenterology. 2004;126(3):693-702.

92Koloski NA, Talley NJ, Boyce PM. Predictors of health care seeking for irritable bowel syndrome and nonulcer dyspepsia: A critical review of the literature on symptom and psychosocial factors. Am J Gastroenterol. 2001;96(5):1340-1349. doi:10.1111/j.1572-0241.2001.03789.x.

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95König J, Wells J, Cani PD, et al. Human intestinal barrier function in health and disease. Clin Transl Gastroenterol. 2016;7(10):e196.

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194American College of Gastroenterology Annual Meeting - Orlando, FL. In: ; 2017.

195QuintilesIMS. Alpha ImpactRx ProVoice Survey - Among Primary Care Physicians with a Certification in Sleep Disorders Who Recommended a Brand of Modified Release Melatonin.; 2017.

196 Among gastroenterologists who recommended herbal products for FD. Alpha ImpactRx ProVoice survey (June 2018).

197 Among gastroenterologists who recommended a chewable prebiotic fiber brand. Alpha ImpactRx ProVoice survey (May 2018).

AThese analyses for the ACG IBS 2014 Monograph were done before IBSREST, which was based on the new SST technology was published in 2016

BIBgard’s targeted delivery to the small intestine and its sustained release "broad brush" action makes it a more distal delivery product. These analyses were done before IBSREST, which was based on the new SST technology was published in 2016.

CThis product, Colpermin, is available in many countries and available online in the USA

 

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