Irritable bowel syndrome affects an estimated 11% of the world's population, causing cramping, bloating, gas, constipation, and diarrhea. Various studies...
Dr. Sayuk[/caption]
Gregory S. Sayuk, MD, MPH
John T. Milliken Department of Medicine
Division of Gastroenterology
Associate Professor of Medicine and Psychiatry
Associate Director, Fellowship Training Program
Washington University School of Medicine
MedicalResearch.com: What is the background for this study?
Response: The primary objective of this analysis, “Plecanatide for Patients with Chronic Idiopathic Constipation and Irritable Bowel Syndrome‒Constipation: Analysis of Abdominal Pain from Four Randomized Phase 3 Clinical Trials,” was to determine the impact of plecanatide on abdominal pain in patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), in addition to comparing efficacy results in patient populations with minimal to mild pain versus moderate to severe pain at baseline. This was a post hoc analysis of data from the four large, phase 3 plecanatide pivotal trials in CIC and IBS-C.
Chase Spurlock, PhD, CEO of IQuity Inc. and
Thomas M. Aune, PhD,
Co-Founder of IQuity Inc.
MedicalResearch.com: Why did you develop IsolateIBS-IBD?
Response: Isolate IBS-IBD arose from work started at Vanderbilt University, which found that autoimmune diseases exhibit distinct RNA patterns in blood and that these patterns often are specific for a particular disease. In our longitudinal and cross-sectional studies of many human conditions that span both autoimmune and non-autoimmune disease categories, we found that differences detected at the level of RNA can provide an accurate snapshot of a person’s disease. Using RNA, we can tell at a very early stage if a pattern exists that indicates a specific disease. With this information, providers can initiate treatment plans sooner and have an additional tool in their toolbox when making diagnostic determinations.
We developed this test because the symptoms of IBS and IBD are very similar, which can make it difficult and time-consuming for doctors to achieve an accurate diagnosis. IsolateIBS-IBD helps providers distinguish between the two conditions. It shouldn’t be viewed as a replacement or stand-alone test — doctors still need to use it in conjunction with clinical observation combined with traditional tests and procedures like a CT scan or endoscopic examination of the colon — but it can dramatically speed the diagnostic process. IQuity delivers results to providers within seven days of receiving the patient’s sample in the laboratory, allowing doctors to begin discussing a course of treatment as soon as possible. 
Dr. Cash[/caption]
Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E.
Professor of Medicine and
Chief of the USA Gastroenterology Division
Director, Motility and Physiology Service
University of South Alabama
Mobile, Alabama
MedicalResearch.com: What is the background for this study?
Response: Irritable Bowel Syndrome (IBS) among patients with IBS-M (mixed diarrhea and constipation) is a challenging and difficult to diagnose and treat sub-type of IBS. Patients with IBS-M represent a dissatisfied group of IBS patients due to the lack of proven therapies. It is an area of high unmet medical need.
Among adult patients with IBS, a sizeable proportion suffers from IBS-M with prevalence rates estimated to be between 44 to 66 percent of IBS sufferers[1],[2],[3]. IBS-M patients carry a heavy burden, characterized by bouts of constipation interrupted by diarrhea and vice versa. Physicians find IBS-M challenging to manage because of the difficulty in avoiding ‘overshoots’ when diarrhea management can turn into constipation and vice versa.[4] 
Dr. Cash[/caption]
Brooks D. Cash, MD
Chief, Gastroenterology Division
Professor of Medicine
University of South Alabama
Mobile, AL 36688
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Irritable bowel syndrome (IBS) is a chronic functional disorder characterized by multiple symptoms including, but not limited to, abdominal pain or discomfort, constipation, diarrhea, urgency of bowel movement (BM), a sensation of incomplete evacuation, pain at evacuation, abdominal bloating, and passage of gas or mucus. IBS can be classified into four primary subtypes: mixed IBS (IBS-M), diarrhea-predominant IBS (IBS-D), constipation-predominant IBS (IBS-C), and unsubtyped IBS (IBS-U). Among adult patients with IBS, a sizeable proportion suffers from IBS-M, with prevalence rates among IBS patients estimated to be between 44% to 66%. Because of the variability in symptoms associated with IBS-M and the lack of effective or approved therapies, clinicians often face challenges in managing this common IBS subtype.
PO and its active ingredient, l-Menthol, are kappa opioid agonists, possess smooth muscle calcium channel antagonist and serotonergic (5HT3) antagonist properties, and exert anti-inflammatory, anti-infective, and carminative effect. A recent meta-analysis of medical therapies for IBS found that PO had the lowest number needed to treat among the various options evaluated. The previously published IBS Reduction Evaluation and Safety Trial (IBSREST) showed that PO-SST, a novel formulation of PO using solid-state microspheres to target delivery to the small intestine, was an effective IBS therapy at 24 hours, with improved efficacy at 4 weeks in a combined group of IBS-M and IBS-D patients. In view of the unmet need in IBS-M, we performed a post hoc analysis of the effects of PO-SST among only the IBS-M patients from the IBSREST trial.