Salem, MA – January 10, 2020 – Commonwealth Diagnostics International, Inc. (CDI) is pleased to participate in a clinical trial with the University of Michigan, one of the largest gastroenterology practices in the country and a leader in the GI community. The clinical trial, Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea (IBS-D), will determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin.
“We are thrilled to work with the University of Michigan and provide our at-home breath test kits to identify SIBO and blood test for IBS for this important study to help improve treatment plans for patients suffering with IBS”, said Lisa Richard, VP, Communications & Market Access.
IBS affects 10-15% of adults in the United States. Not only does this disease cause a variety of symptoms like bloating, diarrhea and abdominal pain, it significantly impairs quality of life. Proper diagnosis and treatment is critical and this trial will help aid in determining the best diagnosis plan and treatment for patients with IBS-D.
Studies have shown an increased prevalence of bacteria in the small intestine in patients with IBS-D symptoms, and other clinical trials show the benefits of a 10-14 day course of rifaximin. CDI will work with the University of Michigan to provide participants with proprietary non-invasive at-home breath test kits to determine if a participant with IBS-D symptoms has SIBO. All breath testing will be administered in the comfort of the patient’s home using clear instructions for use provided by CDI. Blood samples will also be collected using IBSchek®, the first clinically validated blood test for IBS, provided by CDI in an at-home capillary collection kit. The estimated completion date of this study is January 2021.
CDI is a CLIA-certified, FDA registered, ISO 13485 certified diagnostic testing laboratory and medical device manufacturer that specializes in technologies that aid in the diagnosis of some of the most common functional gastrointestinal disorders including Irritable Bowel Syndrome (IBS) and Small Intestinal Bacterial Overgrowth (SIBO).