Clinical Studies

To learn more about the effectiveness and safety of IBgard® for the dietary management of IBS, view the abstract or download a copy of “A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome,” published in Digestive Diseases and Sciences, a peer-reviewed journal.  

An Advance in the Management of IBS: Presented at the world's premier gastroenterology meeting, Digestive Disease Week (DDW)... May 2015

IBgard Clinical Data


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)

Among adult patients diagnosed with IBS, a sizable proportion suffers from a mixed bowel habit pattern. IBS-M sufferers experience a high burden, both in terms of symptoms and quality of life.  There is no FDA approved therapy for IBS-M and it remains an unmet medical need.

After 4 weeks of treatment, the PO-SST arm demonstrated statistically significant reduction in the TISS score (P=0.03) and frequency of IBS symptoms (P=0.03) with near significance (P=0.053) in the intensity of IBS symptoms (Figure 2). For all 8 IBS symptoms measured (Figures 3 and 4), the PO-SST arm had a greater reduction, compared to placebo, that was significant for abdominal pain (P=0.04), constipation (P=0.008), urgency (P=0.036), and sense of incomplete evacuation (P=0.04). PO-SST demonstrated reduction versus placebo in both constipation (P=0.0085) and diarrhea (P=0.2296) in IBS-M. PO-SST is an option for IBS-M, a common IBS subtype, where no approved therapies exist.

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Patient Responder Analysis for a Total IBS Symptom Score (TISS) and Abdominal Pain with a Novel Peppermint Oil Site Specific Targeting (PO-SST) Formulation from the US-based IBSREST Randomized Controlled Trial

There are high placebo response rates with a large amount of variability in IBS clinical trials. Recently, more restrictive outcome measures have been developed for IBS trials to distinguish between active treatment response and placebo response. However, a stringent responder endpoint may not accurately convey the degree of clinical improvement based on patient reported outcomes (PRO). The IBS Reduction Evaluation and Safety Trial (IBSREST) showed that a novel formulation of peppermint oil (PO) using solid-state microspheres (PO-SST) to target the small intestine, was an effective IBS therapy at 24 hours, with improved efficacy at 4 weeks. One previous PRO study, IBSACT*, showed an 80% plus response rate.

A higher percentage of patients responded to PO-SST vs. placebo. The stringent “40% improvement” threshold tended to be pronounced within 24 hours for TISS and abdominal pain, while differences in “any improvement” were retained at 4 weeks for abdominal pain, supporting a consistent effect on abdominal pain with PO-SST. This responder analysis confirmed the high response rates seen with PO-SST in the IBSACT trial.

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Patient Satisfaction with IBS Symptom Relief Using IBgard in a Randomized Clinical Trial and in the General Population

Thirty-five subjects randomized to IBgard in IBSREST (an RCT)§  and 285 patients in IBSACT (a patient reported outcome [PRO] study)§§ were included in this analysis. There was a high satisfaction rate (>80%) with IBgard in both studies. Most patients in the PRO§§ study (60.8%) used 1 to 2 capsules per day, and 75.6% reported

IBS symptom reduction within 1-2 hours of ingestion. Patients in the RCT§ reported significant reduction in IBS symptoms 24 hours after the first dose of IBgard.

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IBgard for Dietary Management of Irritable Bowel Syndrome

Looking at individual symptoms at 24 hours, there was a trend toward a greater improvement with peppermint oil vs placebo in all 8 of the primary IBS symptoms that are measured by the TISS (Total IBS Symptom Score). This difference reached statistical significance in the category of abdominal pain or discomfort, with patients reporting a 21% reduction from baseline vs a 10% reduction with placebo (P<.05). Patients in the peppermint oil arm also had a significantly greater reduction in the intensity of bowel movement urgency at 24 hours compared with patients in the placebo arm (25% vs 6%; P=.0374). At 4 weeks, there was a greater separation in the reduction of individual IBS symptoms between peppermint oil and placebo, and several of these differences were statistically significant. The primary endpoint of the study, reduction in the TISS at 4 weeks, was significantly greater with peppermint oil vs placebo (40% vs 25%; P=.0246). These findings suggest that the difference between peppermint oil and placebo increased from approximately 10% at 24 hours to approximately 15% at 4 weeks. It should also be noted that the 25% response rate observed with placebo in this study is typical of response rates reported with placebo in other functional GI studies.

Full article: Cash, Brooks, “Novel Peppermint Oil Formulation for Dietary Management of Irritable Bowel Syndrome”. Gastroenterology & Hepatology Volume 11, Issue 9 September 2015. Pg 631-633.

 

IBgard, a novel, small-intestine-targeted delivery system of peppermint oil, results in significant improvement in severe and unbearable IBS symptom intensity.

Approximately 25% of patients with irritable bowel syndrome (IBS) describe their symptoms as severe. Multiple items (mean=7) have been identified as contributing to IBS severity. The level of severity seems related to the number and intensity of these contributing factors. High severity is reflected by higher intensity and higher frequency of individual symptoms.

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IBgard, a novel, targeted-delivery system of peppermint oil, results in significant improvement in the Total IBS Symptom Score and individual IBS symptoms.

Peppermint oil (PO) has been shown to significantly reduce global symptoms as well as the abdominal pain of irritable bowel syndrome (IBS).1 It is approved by the European Medicines Agency (EMEA) and used as a first line IBS therapy outside the United States.

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24 hour results from the IBSREST™ trial: a U.S.-based, randomized, placebo-controlled, multi-centered trial, to evaluate a novel peppermint oil delivery system.

Irritable bowel syndrome (IBS) is a chronic disorder with periodic exacerbations of symptoms that can be severe. The incidence of the 3 major forms of IBS has been reported as IBS-M (61.0%), IBS-D (29.3%), and IBS-C (9.7%).

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Targeted delivery of peppermint oil to the small intestine provides significant improvement in the syndrome of symptoms associated with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic disorder with periodic exacerbations of eight major symptoms, including abdominal pain or discomfort, abdominal bloating, constipation, diarrhea, incomplete evacuation, pain at evacuation, passage of gas or mucus, and urgency of bowel movement.

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