At-home gluten test to be evaluated in clinical studies
Two hospitals with ties to the Harvard Medical School Celiac Research Program will investigate an at-home test called Gluten Detective designed to monitor gluten consumption in people on a gluten-free diet.
Launched in November 2017, the Gluten Detective test (Glutenostics) uses the G12 antibody to recognize the 33-mer fragment of gluten in stool or urine samples to help individuals determine if they have inadvertently consumed food containing gluten within the past 24 to 48 hours.
In one of the trials, Jocelyn Silvester, MD, PhD, director of research for the Celiac Disease Program at Boston Children’s Hospital and colleagues will study the test’s effectiveness in 200 children with celiac disease.
“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%] of people on a strict gluten-free diet are still accidentally consuming gluten,” Silvester said in the press release. “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.”
Investigators in a second ongoing study at Massachusetts General Hospital’s Center for Celiac Research will soon add urine and stool analysis to their search for a potential link between inadvertent gluten consumption and intestinal healing.
“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,” Maureen Leonard, MD, MMSc, clinical director of the Center, said in the press release.
Glutenostics also reports collaborating with other researchers nationwide to investigate the impact of gluten contamination in the diet of people who avoid gluten for medical or other reasons, according to the press release. The company expects study results to be published “over the coming months and years.”
Disclosures: Healio Gastroenterology and Liver Disease was unable to confirm Silvester’s and Leonard’s relevant financial disclosures prior to publication.