Patient EducationJun | 30 | 2022
Part of the Solution: What It’s Like to Participate in a Clinical Research Study (Gluten Challenge) on Celiac Disease
Currently, a gluten-free diet is the only treatment available for someone who has been clinically diagnosed with celiac disease. So, what happens to a celiac patient if or when they are temporarily re-exposed to gluten?
At the Center for Celiac Research and Treatment at Mass General for Children, researchers, under the leadership of center director and principal investigator Alessio Fasano, MD, are uncovering answers to this question through a number of initiatives, including exposing study participants to gluten during a 14-day challenge.
The center is now enrolling patients ages 18 to 75 with biopsy-proven celiac disease who have been on a gluten-free diet for at least 6 months. Participation includes six visits over 15 weeks, and financial compensation and meals are offered.
During the 14-day challenge, each participant consumes a defined amount of gluten, tracks their daily symptoms, and visits the celiac center for diagnostic procedures including blood draws, an endoscopy, a biopsy and urine samples. The research team studies the samples to evaluate how gluten changes the disease biomarkers in each participant’s gut and blood.
A Conversation with a Participant in Our Study
Lisa* completed the 14-day gluten challenge in 2021. During an exit interview, she shared her motivations for participating in the study and her daily or lived experiences managing celiac disease. (What follows is an excerpt from a longer interview.)
Q. Lisa, when did you know you had celiac disease?
It started in 2018 with a weekend family trip to New York City—complete with a shared, Italian-style dinner, including lots of pizza and pasta. Before that trip, I knew that I always felt better when I didn’t eat gluten, but during that weekend, I got severely sick.
Q. What were your symptoms?
It wasn’t just gastroenterological issues; I just didn’t feel myself. I also had neurological issues, and it was a scary place to be. But I still didn’t make the celiac connection.
Q. Describe your diagnostic journey from there.
Back in Massachusetts, I went from being told that I didn’t have celiac and didn’t need to be tested, to a provider who agreed to a blood test, which came back positive. Based on this result, I knew I needed to self-advocate for an endoscopy. Eventually, I switched to Mass General and the celiac team here.
Q. How did you hear about the 14-day gluten challenge?
Since I’m already a patient at Mass General, I got an invitation through the hospital’s patient portal. I had received invitations for other clinical studies, but I was really excited about participating in this one.
Q. What was so exciting about this particular study?
Research is so important, and I wanted to be part of the solution in a very small way. I loved the thought that someday the research might lead to some type of medication or something that we could take and maybe eat gluten again.
The second motivator was that every single experience that I’ve had here with the Mass General nurses, doctors and dietitian has been phenomenal. So, I had no fear or concerns about the gluten-challenge office visits and the required endoscopies or other procedures.
Q. While on the challenge, what was your day-to-day experience like?
Gluten makes me really tired, so that was my major experience or complaint throughout the two weeks of the study. However, though I felt sluggish, I was still able to do my work. Also, after the first endoscopy, I was a little bit groggy, especially because I had to eat the gluten right away, but it didn’t affect anything else in my life. Overall, it was a very positive experience.
Q. What advice would you give to someone who is undecided about participating in a gluten challenge?
I had some fear going into this challenge. But every time I got to the hospital for the required office visits and procedures, that fear went away, and I realized that everything would be fine. Also, it was fascinating to see the research side of the hospital—a side that, as a celiac patient, you don’t usually get to see. It’s so inspiring to see how devoted the research team members are here. Overall, it was a positive experience, and if you have some fears, don’t worry, as the team have got you covered.
Would you like to contribute to the science around how we understand, treat and possibly prevent celiac disease? The Center for Celiac Research and Treatment is actively enrolling Massachusetts-based participants for our 14-day gluten challenge. Learn more or request more information on the website or via email email@example.com.
*The patient’s name has been changed to protect privacy.