Study reaffirms safety and tolerability profile of leading IBS medical food

BOCA RATON, Fla. - IM HealthScience on Monday announced favorable results from its Irritable Bowel Syndrome Safety Update at 6 Months (IBSSU-6), a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 163,165 patients who used the product.  

The results found no serious adverse events. Additionally, the rates and patterns of non-serious adverse events were low (0.05% or 89 people out of 163,165 patients studied) and generally consistent with those normal adverse events commonly associated with an IBS population. These non-serious adverse events included dyspepsia, nausea, abdominal pain and diarrhea.

"Real-world research is a vital component to clinical trials and helps with defining management options for patients," stated Michael  Epstein, a leading gastroenterologist and chief medical advisor for IM HealthScience. "The findings from IBSSU-6 reaffirm the safety and tolerability profile of IBgard in real-world settings and show the use of IBgard is consistent with the adverse events reported in our landmark clinical trial, IBSREST (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial)," he said. "Heartburn and anal burning are common side effects associated with older peppermint oil products. However, in IBSSU-6, there were no reports of anal burning and reports of heartburn were remarkably low, no different than what physicians see as existing co-morbid conditions in the patient population suffering from IBS."