BOSTON, April 23, 2018 /PRNewswire/ -- Glutenostics LLC, today announced plans for two important clinical studies involving "Gluten Detective" technology, the first at-home product designed to monitor gluten consumption, to help people on a gluten-free diet maintain compliance. Two organizations from the Harvard Medical School Celiac Research Program are conducting the research in collaboration with Glutenostics.
"Today, we are pleased to announce plans for two exciting and innovative clinical studies we are undertaking with acclaimed Harvard institutions and researchers at Boston Children's Hospital and Massachusetts General Hospital," said David Winternheimer, PhD, CEO of Glutenostics. "These studies will contribute to improving the management of the gluten-free diet in our communities."
Gluten Detective was launched in November 2017 as the first at-home, gluten-consumption monitoring kit for people on a gluten-free diet to assess whether they have inadvertently consumed gluten. Since the launch, the company has received an overwhelming degree of interest from gluten-free consumers and members of the medical community, as well as from pharma industry partners interested in using the technology in their clinical research. The gluten detection technology behind Gluten Detective (the G12 antibody recognizes the 33-mer fragment of gluten) has been used in numerous clinical studies to date. The upcoming studies are the first to be done in home settings in North America.
Boston Children's is recruiting 200 children with celiac disease for its study. "We've done some prior work looking at gluten levels in food as well as in urine and stool samples, and we found that 20 to 40 percent of people on a strict gluten-free diet are still accidentally consuming gluten," notes Jocelyn Silvester, MD, PhD, director of research for the Celiac Disease Program at Boston Children's and principal investigator for one of the studies. "In this new study, we will see if patients who have access to at-home testing results improve in their ability to comply with the diet over the course of six months compared to those without this at-home monitoring tool."
Meanwhile at Mass General, researchers in an ongoing study will soon be adding urine and stool testing to the study's protocol. "As many as 20 percent of pediatric celiac patients fail to heal after a full year on the gluten-free diet," says Alessio Fasano, director of the Center for Celiac Research and Treatment at Massachusetts General Hospital. The Center's clinical director, Maureen Leonard, MD, MMSc, is principal investigator for the second study. "By examining intestinal biopsy results of patients over a 1 to 3 year period, and by comparing these results with that of gluten content in urine and stool, we'll look for a correlation between intestinal healing and gluten contamination," says Leonard.
"The year 2018 will be an exciting one for us and the gluten-free community," notes Winternheimer. "We're looking forward to some very interesting results and publications coming out of our and our partners' work over the coming months and years."
In addition to the Harvard studies, Glutenostics collaborates with several other partners at major healthcare institutions nationwide to answer additional questions on the impact of gluten contamination in the diet of consumers avoiding gluten for medical or other reasons. It has long been suspected that people on the gluten-free diet accidentally consume gluten on a regular basis. Results from Gluten Detective urine and stool tests, along with Glutenostics' laboratory G12-antibody-based assays, amplify the rapidly emerging evidence that scientifically validates this hypothesis.
Glutenostics was founded in 2016 with the mission of bringing new technologies to market that improve the livelihood of those living gluten-free, regardless of reason. In 2017, Glutenostics licensed its first technology from Biomedal (Seville, Spain) and developed its first product line, Gluten Detective, now available exclusively via its website www.glutendetective.com. As Glutenostics continues to grow and expand, it continues to pursue partnerships with other technology innovators in the gluten-free and surrounding space to commercialize those products in North America.
SOURCE Glutenostics LLC