- IBgard® demonstrated to be an effective, safe and well tolerated option to address unmet need for patients with IBS
- Rapid and symptomatic improvement of the most bothersome gastrointestinal symptoms at 24 hours and at four weeks
- First clinical trial to use patented Site Specific Targeting (SST®) technology delivering peppermint oil in microspheres to the small intestine
New York, and Boca Raton, Fla. – (October 5, 2015) – IM HealthScience® today announced that Digestive Diseases and Sciences, a prestigious, peer-reviewed medical journal in the fields of gastroenterology and hepatology, has published the results of the IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study. The hard copy version of this randomized, placebo-controlled, multicenter trial will follow the online August 29, 2015 publication. The study entitled, “A Novel Delivery System of Peppermint Oil is an Effective Therapy For Irritable Bowel Syndrome,” is now accessible to the public via open access on the home page of the Digestive Diseases and Sciences website.
Now in its 81st year of publication, Digestive Diseases and Sciences, formerly named The American Journal of Digestive Diseases, publishes high-quality, original studies on basic research and clinical practice in gastroenterology, hepatology and related fields. According to Brooks D. Cash, M.D., the lead study author and Professor of Medicine in the Gastroenterology Division at the University of South Alabama in Mobile, “This landmark study not only received considerable attention in May at Digestive Disease Week (DDW), one of the premier annual scientific gastroenterology meetings, but it is also gratifying to see this prestigious journal select this study for publication.”
The IBSREST™ study demonstrated that IBgard® provided reduction in eight hallmark symptoms of IBS: abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus at 24 hours and at four weeks. IBgard® is specially formulated for the dietary management of IBS. It is the first product using a patented, breakthrough technology, called Site Specific Targeting (SST®) to deliver sustained released microspheres of an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions helps manage IBS.
Dr. Cash continued, “The IBSREST™ study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel formulation of peppermint oil for managing symptoms of IBS over an extended period.” In the study, IBgard® was found to be effective, safe and well tolerated (comparable to placebo). Patient satisfaction in the treatment arm was an important endpoint of the trial and on this measure satisfaction reached a 93 percent level.” The results of IBSREST™ were first presented in May 2015 during DDW.
About the Study
The IBSREST™ study was a 4-week, randomized, placebo-controlled, double-blind clinical trial conducted at multiple centers in the U.S. in which 72 patients were randomized to IBgard® (n = 35) or placebo (n = 37) with 3 doses daily for four weeks. Analysis of IBSREST™ data showed that treatment with IBgard® demonstrated a 20 percent reduction in the Total IBS Symptom Score (TISS) from baseline in as early as 24 hours, which was a statistically significant reduction compared to placebo (P= 0.0092), and a 40 percent reduction in the TISS from baseline at four weeks, which was also significant compared to placebo (P = 0.0246).
“The results of this high-quality study highlight an advance in the management of IBS, because IBgard® addresses a significant unmet medical need for products to manage the symptoms of the disease, especially for IBS patients with mixed diarrhea and constipation (IBS-M) and diarrhea predominant (IBS-D),” Dr. Cash noted. “It is estimated that the majority of the IBS patient population is comprised of the IBS-M and IBS-D subtypes.”1
About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, underdiagnosed and undertreated condition characterized by abdominal pain associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS.
Doctors are not sure what causes IBS and it is likely that there are numerous etiologies that manifest as a similar syndrome of symptoms. There is currently no cure for IBS and management options are limited.
IBgard® capsules contain L-menthol, the principal component in peppermint oil, which has been shown to have significant impact on the management of IBS symptoms. In multiple clinical studies, peppermint oil has been shown to provide relief from IBS symptoms. With its patented SST® technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, in the small intestine. Peppermint oil can help normalize the digestion of food and absorption of nutrients, which have been compromised by IBS.
Peppermint oil has also been shown to normalize intestinal transit time.
Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. While IBgard® does not require a prescription, it should be used under medical supervision. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.
IBgard® is now accessible to consumers in the digestive aisle at most CVS/pharmacy and Walgreens stores nationwide.
1Drossman et al. J. Clin.Gastroenterol. 2009:43(6) 541-550.
About IM HealthScience®
IM HealthScience® is a privately held company based in Boca Raton, Florida, that developed IBgard®. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Ulcerative Colitis, and Crohn’s Disease. The IM HealthScience® advantage comes from developing products based on its patented, targeted- delivery technologies called Site Specific Targeting (SST®). For more information, visit
www.IBgard.com to learn more about IBgard®.