The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. Patients suffering from IBS-M and IBS-D were included in the study.
Ultramen peppermint oil trial#
IBgard previously was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called IBSREST™ ( Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). Additionally, peppermint oil has also been shown to help normalize intestinal transit time. The food nutrients in IBgard (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS patients and help normalize gut mucosal barrier function.
With its patented Site Specific Targeting (SST ®) technology, pioneered by IM HealthScience, IBgard capsules release Ultramen ®, an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS.
Ultramen peppermint oil plus#
IBgard capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, plus fiber and amino acids (from gelatin protein), in a unique delivery system. IBgard® is a medical food specially formulated for the dietary management of IBS. The top-reported, non-serious adverse events were abdominal pain/discomfort/distension (65), diarrhea (59), dyspepsia (56), constipation (29), flatulence (27), and throat irritation (27). Only 626 non-serious adverse events were received, many of which were consistent with commonly reported symptoms of IBS. An analysis of the data by reviewers showed that there were no reported serious adverse events associated with the use of IBgard during this time frame. The adverse events for this study were collected and processed from Octoto September 30, 2017. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events was retained to receive and record IBgard customer questions, product issues, and adverse events. An independent call center with pharmacovigilance-trained health care personnel in accordance with U.S.
Ultramen peppermint oil update#
The Irritable Bowel Syndrome Safety Update at 24 Months (IBSSU-24) is a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 773,322 individual patients who used the product. However, in IBSSU-24, there was only 1 report of anal burning and 7 reports of gastroesophageal reflux disease (GERD), which is remarkably low." Epstein added, "Heartburn and burning are common side effects reported with older peppermint oil products. In fact, it may be difficult to separate the scatter of the events from background noise associated with the IBS population."ĭr. The outcome does not cause any concern for the safety profile of the product. This calculation results in an estimated 0.07 percent adverse event reporting rate for IBgard. "The findings from IBSSU-24 reaffirm the safety and tolerability profile of IBgard in real-world settings. Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. "It is not common for a pharmaceutical-level, post-marketing safety monitoring study to be conducted for a medical food," said Michael S. The IBSSU-24 captured and analyzed serious and non-serious adverse event reports for IBgard over a 24-month period from Octoto September 30, 2017.
Both symptoms are very commonly reported in patients with Irritable Bowel Syndrome (IBS). The top-reported, non-serious adverse events were abdominal pain/discomfort, and diarrhea. Additionally, the self-reporting rates and patterns of non-serious adverse events were low with only 626 events received.
It is estimated that 773,322 individual patients used the product since the beginning of the surveillance. BOCA RATON, Fla., Ap/PRNewswire/ - IM HealthScience ® (IMH) today announced favorable results from its Irritable Bowel Syndrome Safety Update at 24 Months (IBSSU-24), a real-world surveillance study reporting on the safety and tolerability profile of IBgard ®.
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