A new medical food for irritable bowel syndrome (IBS)

IM HealthScience has 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 randomised, placebo-controlled, multicentre trial will follow the online 29 August 2015 publication. The study, titled, '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, MD, 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, diarrhoea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus at 24 hours and at 4 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 to 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 during an extended period. In the study, IBgard was found to be effective, safe and well tolerated (compared with a placebo). Patient satisfaction in the treatment arm was an important endpoint of the trial and on this measure satisfaction reached a 93% level.'

About the study

The IBSREST study was a 4-week, randomised, placebo-controlled, double-blind clinical trial conducted at multiple centres in the US in which 72 patients were randomised to IBgard (n=35) or a placebo (n=37) with three doses daily for 4 weeks.

Analysis of IBSREST data showed that treatment with IBgard demonstrated a 20% reduction in the Total IBS Symptom Score (TISS) from baseline in as early as 24 hours, which was a statistically significant reduction compared with the placebo (P=0.0092), and a 40% reduction in the TISS from baseline at 4 weeks, which was also significant compared with the 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 diarrhoea and constipation (IBS-M) and diarrhoea predominant (IBS-D),' Dr Cash noted. 'It is estimated that the majority of the IBS patient population comprises the IBS-M and IBS-D subtypes.'