For someone with celiac disease, a gluten-free diet is the only treatment. Continued exposure to gluten damages the lining of the intestines, at best causing gastrointestinal distress and at worst leading to irreparable harm.
"The most important thing you can do for a patient after a diagnosis of celiac disease is have them see an expert dietitian and learn the gluten-free diet so they can avoid repeated exposures to gluten and lower their risk for complications," says Benjamin Lebwohl, a gastroenterologist at Columbia and director of clinical research at Columbia's Celiac Disease Center.
But even people who are on the diet may occasionally ingest gluten, so at-home tests were created to help people find out if they've had a recent exposure. The tests detect fragments of gluten-the protein in wheat, barley, and rye responsible for celiac disease-in urine within hours of exposure.
"The urine tests, which have been available to consumers for several years, really do identify gluten if you have been exposed," says Lebwohl. "But patients pay for them out of pocket, and nobody has ever studied whether they actually benefit patients with celiac disease."
Now, Lebwohl and other researchers at Columbia are launching a multicenter clinical trial to find out if using the tests to detect gluten exposure could improve knowledge of and compliance with the celiac diet, intestinal healing, and quality of life for patients living with celiac disease.
The challenge of going gluten-free
An estimated 2 million people in the United States have celiac disease, a chronic immune disorder in which the intestinal lining becomes inflamed after ingesting gluten. Intestinal inflammation can cause a range of gastrointestinal issues, malnutrition, chronic fatigue, and other symptoms. Ongoing intestinal inflammation interferes with nutrient absorption, which can increase the risk of anemia, osteoporosis, and certain cancers.
But given the ubiquity of gluten, occasional inadvertent exposures-sometimes through cross-contamination-are inevitable.
"Avoiding gluten at restaurants or in other people's homes can be very difficult, triggering anxiety, hypervigilance, and social avoidance for some patients," says Randi Wolf, a behavioral education expert at Columbia and co-leader of the study.
How the trial works
The study will enroll up to 200 people at Columbia, Harvard, University of Chicago, and Vanderbilt University who have been recently diagnosed with celiac disease with blood tests and intestinal biopsy.
All participants will meet with a registered dietitian to learn the gluten-free diet. They will also have the opportunity to raise additional questions about avoiding gluten exposure and related quality-of-life issues in several follow-up video visits.
Half of the participants will be randomly chosen to receive at-home gluten tests. People in this group will be instructed to use the tests at least once a week and more often if gluten exposure is suspected, particularly after eating out or experiencing symptoms.
After a year, patients will have additional blood work and a second biopsy to see if the diet is working and report any changes in symptoms and quality of life.
The investigator-initiated trial is funded by the National Institutes of Health; a portion of these funds is being used to purchase test kits from the manufacturer, which is not involved in the study.
Understanding how the technology may help is key
The researchers hope to see greater improvement in symptom control and intestinal healing in the group using the at-home gluten tests.
And if the test kits help participants, the researchers want to know why.
"Maybe the tests will increase people's confidence in adhering to the celiac diet or improve their knowledge about places they're likely to be exposed to gluten," Wolf says. "If we can determine who is most likely to benefit, we can offer the tests to more patients as part of routine management."
It's also possible that at-home tests may make some people overly cautious and reduce their quality of life.
"Management of celiac disease is evolving, and we are hoping this trial will give us information about whether gluten-detecting technologies can make a difference after patients have been diagnosed," Lebwohl says.
References
More information
Benjamin Lebwohl, MD, is professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and professor of epidemiology at Columbia University Mailman School of Public Health.
Randi Wolf, PhD, is professor of human nutrition at Columbia University Teachers College.
To learn more about the trial, visit: https://www.glutechtrial.org.
