Celiac disease is the only auto-immune disease that can be managed with diet. Celiac disease (CD) is a gluten-triggered autoimmune disorder of the small intestine. Despite following a strict gluten-free diet that involves lots of meal-planning, calling ahead to restaurants and intensive label-reading, some celiacs still experience symptoms after accidental exposure.
There is currently no approved treatment for the condition but Dr. Justine Turner, a professor in the Division of Gastroenterology and Nutrition, Department of Pediatrics, at the University of Alberta is running a clinical trial exploring a supplement for individuals with celiac disease who continue to be plagued with chronic fatigue, diarrhea and abdominal pain, among other ailments. It is sponsored by Vetanda, a U.K. company.
“There are many reasons people still get exposed and still have symptoms,” says Turner. “But it’s not just people that are deliberately eating gluten, it’s the people that are trying really hard to be strict about their diet and they sometimes still get exposed inadvertently.”
The study, of which Turner is the lead researcher, is examining the effectiveness of AGY (Anti-Gliadin Y) in conjunction with a gluten-free diet, to help patients eradicate their symptoms. But, it is not a cure.
“You’ll sometimes see things that are over-the-counter products that are advertised as treating celiac disease and that’s actually misleading, that’s not true. There is no approved treatment right now,” says Turner.
The trial is still actively recruiting and is expected to wrap up early next year, upon which the results will be analyzed and eventually published.
The trial is based on previous research conducted by former University of Alberta Associate Professor of Pharmacy and Pharmaceutical Science Hoon H. Sunwoo, who pioneered the science behind AGY. He told CBC in 2015 that his research was inspired by a friend of his who was celiac and the fact that they couldn’t enjoy a beer together.
Turner says Sunwoo now works for the sponsoring company, Vetanda as their scientific officer. He is unable to directly participate in the trial due to being the inventor of the product. According to its website, Vetanda has purchased all patents and trade secrets for the products.
Sunwoo and Vetanda did not respond to multiple requests for comment.
Based on Sunwoo’s work, researchers immunize hens to produce their own antibodies to gliadin, the protein in gluten that stirs a reaction in celiac individuals. The antibody becomes concentrated in the yolk of the egg and is then extracted and encapsulated for oral use.
Prior to the launch of this current trial, which currently sits at 40 participants and will be capped at 149, there was a 10-person pilot study conducted in 2015 to ensure the safety of the treatment before it was given to a larger population. The 10 patients in the pilot study were celiacs who had been on gluten-free diets for five years and were still experiencing symptoms.
“There was an improvement for those adult patients in the pilot study in their symptoms which is remarkable because [the pilot study] wasn’t designed to show that it worked, it was designed to show that it was safe,” says Turner.
According to the 2017 published study in the journal Digestive Disease and Sciences, most patients had fewer celiac symptoms (especially tiredness, headache, and bloating), improved quality of life and lowered antibodies.
The current study takes place over 15 weeks during which patients will receive both the AGY capsule and the placebo, which look identical. Neither the researchers, clinicians, or patients know which treatment they are taking at any given time. Both pills will be taken for four weeks, with a week gap in between, and a month-long follow-up period. There is also time allotted prior to treatment for preliminary testing, including requirements for eligibility, such as blood tests.
Study participants are required to take two capsules prior to each meal, up to a maximum of eight capsules per day. They are also monitoring their symptoms and recording their diet while having regular blood and urine tests.
The trial was initially led by Dr. Richard Fedorak and Turner was recruited after his passing in 2018. She emphasizes that it is important for clinicians to be involved in clinical trials not only to recruit patients but to “[monitor] any clinical risks or problems that may arise during the trial.”
Celiac patients will have to wait to get their hands on the pill if the trial is successful, after it goes through an approval process. Although Turner says that this process could be shortened due to the fact that the supplement itself is not altered or modified, which classifies it as a “natural health product.”
The pilot study showed success in the participating patients and Turner is looking forward to the completion of the 149-patient trial, in which she hopes there will be similar results.
“It’s very promising and we are hopeful,” says Turner.
To be eligible to participate in the study, individuals must have a history of celiac disease, experience periodic celiac related symptoms and have been following a gluten free diet for at least 12 months.
Individuals who have severe complications of celiac disease or chronic active gastrointestinal disease, type 1 diabetes, are pregnant, breastfeeding or use ASA (acetylsalicylic acid/Aspirin) and NSAIDs (nonsteroidal anti-inflammatory drugs/Ibuprofen) daily are not eligible for participation in this study.
If you are looking for additional information regarding the study or interested in exploring your eligibility, you can contact Dory Sample at firstname.lastname@example.org.
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