Results Of Confirmatory Clinical Trial Presented At The American Gastroenterological Association's (AGA) Freston Conference Support IBgard® As A New Approach In Managing Irritable Bowel Syndrome (IBS)

CHICAGO, Aug. 31, 2015 /PRNewswire/ -- World-renowned medical and scientific thoughtleaders gathered to discuss cutting-edge scientific and clinical insights as well as current and emerging treatments and management options for patients suffering from irritable bowel syndrome (IBS) at the 2015 James W. Freston Conference: A Renaissance in the Understanding and Managing of Irritable Bowel Syndrome. This conference, hosted by the American Gastroenterological Association (AGA), attracted top scientists, clinicians and health care professionals.

The confirmatory clinical trial, entitled IBSRRET^™ (Irritable Bowel Safety and Response Rate Evaluation Trial), demonstrated a significant decrease in intensity of symptoms, including abdominal pain and discomfort, bloating, constipation, diarrhea, sense of incomplete evacuation and urgency. This trial reconfirmed the outcome from the original IBSREST^™ study done with IBgard^® which showed significant reduction in total IBS symptoms at 24 hours and at 4 weeks.

IBgard^® is a medical food specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST^®) to deliver individually triple-coated, sustained release microspheres of Ultramen^®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions helps manage IBS. The developmental formulation used in IBSRRET^™ contained identical levels of L-Menthol and also benefited from SST® delivery.

"This single-arm 2015 IBSRRET™ trial confirmed the outcomes from the 2014 IBSREST™ trial," said Michael S. Epstein, M.D., lead author of the study and Chief Medical Advisor, IM HealthScience^®, LLC. "This trial demonstrated that targeted delivery of L-menthol decreased the symptoms of IBS over the 4 weeks of treatment. By deploying the novel Site Specific Targeting^® technology, IBgard^® delivers L-menthol quickly and reliably to the small intestine where it is needed most in IBS." 

There were no treatment-related adverse events reported.

In a post-study assessment, 100% of the subjects responded they would likely or definitely recommend the medical food to family or friends who have IBS, were likely or very likely to continue taking the study product and were willing to be contacted in the future about the study product. IBSREST™ also showed high patient satisfaction outcome metrics at 4 weeks.

IBSRRET™ Confirmatory Clinical Trial
IBSRRET™ was a four-week, single-arm, confirmatory clinical trial of 16 patients with the two most prevalent types of IBS, mixed diarrhea and constipation (IBS-M) and diarrhea predominant (IBS-D), conducted at multiple centers in the U.S.

The primary analysis of this clinical trial, entitled IBSRRET™ (Irritable Bowel Safety and Response Rate Evaluation Trial), reported changes in the TISS (Total IBS Symptom Score), a previously studied global symptom measure, as well as the average of the frequency and intensity of the eight symptoms that customarily constitute the IBS syndrome of symptoms: abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus.

IBSREST^™ Clinical Trial
IM HealthScience^® recently presented results of a clinical trial recently conducted in the United States. This clinical trial, entitled IBSREST^™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), was a randomized, placebo-controlled trial of IBgard^® at four sites across the United States. This clinical trial showed unprecedented efficacy and safety for IBgard^® and was selected by a committee of gastroenterology experts for four poster sessions and one oral presentation at the plenary session during Digestive Disease Week (DDW), a premier gastroenterology meeting of the American Gastroenterological Association in Washington, D.C., in May 2015. This meeting is the largest gastroenterology meeting in the world with 15,000 attendees. A standing-room-only gathering heard this oral presentation on May 18, 2015. At this presentation, the 24-hour onset of action of IBgard^® was discussed and commented upon by the gastroenterology experts during the meeting.

About IBgard^®
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. For more information, visit www.IBgard.com to learn more about IBgard^®.

About Irritable Bowel Syndrome
Irritable Bowel Syndrome is a frustrating, underdiagnosed and undertreated condition that irritates the bowel and can disrupt the digestion of food and absorption of nutrients. It affects an estimated 15-20 percent of the U.S population. People who have IBS often experience distressful digestive symptoms, some of which can be severe or unbearable. Abdominal pain, bloating and altered abdominal bowel habits are examples of these symptoms.

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^®.

SOURCE IM HealthScience

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