Community survey results to be shared at largest meeting of doctors and researchers in gastroenterology
By Amy Ratner, Medical and Science News Analyst
Beyond Celiac research into how willing patients are to participate in celiac disease studies has been selected for presentation at the upcoming 2020 Digestive Disease Week.
An abstract detailing the results of a community survey of about 4,500 adults with celiac disease has been approved as a poster presentation at DDW, which is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW will take place in May in Chicago.
People who have celiac disease are willing to participate in celiac disease research, but less so if a study involves eating gluten or getting a biopsy, the Beyond Celiac survey found. The survey was done prior to the recent Beyond Celiac Research Summit and results were shared there. Nearly 500 parents of children with celiac disease also completed a separate survey.
Only about 9 percent of both adults and parents said they would not participate or allow participation in any kind of celiac disease research.
“Our goal is to help scientists and those with celiac disease better understand one another. Presenting this work at DDW will help us educate the scientific community about the celiac disease community’s views of clinical trials,” said lead abstract author Kate Avery, MPH, Beyond Celiac director of research and patient engagement. “We hope this will lead to celiac disease clinical trials that are more friendly to study participants and more research into the celiac disease community’s perspective.”
Overall, nearly 64 percent of adults surveyed said they would be willing to participate in a clinical trial for a drug to treat celiac disease. But the number dropped in almost every case when people were asked about specific clinical trial requirements.
About 13 percent said they would be willing to consume some amount of gluten for four to six weeks. About 26 percent said they would be willing to do a shorter gluten challenge of one to three doses. Nearly 40 percent said they would be willing to have an endoscopy and biopsy.
Those willing to take a medication, keep a symptom diary, share their past medical records or take a stool test hovered around 50 percent.
The largest number, 86 percent, were willing to complete surveys, followed by 69 percent who would take a blood test and nearly 62 percent who would take a urine test.
When the survey was broken down by gender, with about 3,700 women and 700 men, men were more willing to complete components of clinical trials that overall were less appealing to celiac disease patients — consuming a gluten challenge and taking a medication. They were less willing to keep a symptom diary, complete surveys or take a blood test.
Responses from parents of children with celiac disease parallel those from adults. About 8 percent would let their children have a long gluten challenge, while 20 percent would allow a shorter one. Additionally, 20 percent would agree to a biopsy for their children as part of a study.
Parents would be most willing to fill out symptom diaries, share past medical records, and have their children have blood, urine and stool tests. Parents were more reluctant to have children take a medication, with about 35 percent willing.
The survey was sent out in October via email and social media by Beyond Celiac and the Canadian Celiac Association. In addition to asking about willingness to participate in clinical trials, the survey included questions about demographics, diagnosis, gluten exposure and the difficulties associated with having celiac disease.
More than half of adults surveyed said celiac disease has caused them to skip an activity or experience in the previous month and had at some point led them to sacrifice things like a new job, vacation or an opportunity to move.
About 58 percent of parents said celiac disease had dictated decisions for their family, including skipping a vacation or which school their child should attend. About 42 percent of children had missed an activity in the previous month.
Unintentionally consuming gluten was also frequently reported, with about a quarter of adults and 16 percent of parents of children saying accidental gluten exposure happened at least twice a month. Another 20 percent of both groups said they were not sure how often gluten exposure had occurred.
The fact that it is nearly impossible to completely avoid gluten from cross-contact even on a strict gluten-free diet and the impact that has on health and quality of life for those who have celiac disease is one of the reasons alternative treatments are needed are being pursued by celiac disease researchers.
“We are grateful that so many people responded to the survey, both adults and parents because the patient voice in research needs to be heard,” said Alice Bast, Beyond Celiac chief executive officer. “The information shared can help us focus on what patients need to know about different aspects of clinical trials.”
It’s also important to meet patients where they are and let them know there are a number of different ways to contribute to the study of celiac disease, Bast noted. For researchers, the survey reveals how recruitment of men might have an impact on participation in clinical trials, Bast said.