Oral AGY for Celiac Disease
Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of the small intestine to gluten causes an inflammatory response, leading to the destruction of intestine lining, often with severe symptoms including diarrhea, abdominal distention, fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the only treatment currently available is strict adherence to a life-time gluten free diet (GFD). However, adhering to this diet is difficult as gluten proteins are found in many food products. Therefore, the gluten-free diet has both lifestyle and financial implications for the individual and thus has been potential for impacting adversely on their quality of life.
Various approaches are being studied to reduce the need for careful control of the diet for those with CD, including the use of antibodies such as IgY. IgY is produced from the egg yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal toxicity, for those without egg allergy, and offer low-cost, hygienic production of study product. Once the IgY antibody is put into capsule form, it is called AGY.
Individuals with CD will be recruited only if they have a history of biopsy proven CD within 5 years of study entry, currently follow a GFD but continue to have mild to moderate symptoms related to gluten exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at screening, and an elevation will be required (confirming gluten exposure despite a presumed gluten free diet) to enter the study. Those enrolled will have a 2 week run-in period where diet and symptoms are recorded, and will then receive AGY capsules to take with meals over a 4 week period. Outcomes will be measured by examining lab test results including antibody levels, symptoms, and quality of life.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Use of an Orally Administered Antibody to Gluten to Prevent the Recurrence of Symptoms and Laboratory Parameters in Persons With Celiac Disease (Gluten Sensitive Enteropathy)|
- general safety [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]Safety measures will include adverse events and lab test results, will be measured throughout the study period of approximately 6 weeks. In the event of serious symptom development, participants will be asked to return to clinic as soon as possible for an evaluation.
- Symptoms [ Time Frame: daily for 16 weeks ] [ Designated as safety issue: Yes ]Symptoms of Celiac disease will be self-measured by participants daily for the entire 6 week study period using the Celiac Symptom Index tool.
- Health Related Quality of Life [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]health related quality of life will be measured at 4 time points using a validated tool; baseline, week 2, week 4, and at the end of the study at week 6
- ATG antibody level [ Time Frame: screening through final visit ] [ Designated as safety issue: Yes ]The ATG antibody level will be measured at screening (elevation required for study entry), baseline, week 2, week 4 and week 6.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
All participants will receive the same, open-label dose of AGY
AGY is a natural health product produced in egg yolks
The trial will last approximately 6 weeks. Individuals will be screened to ensure they are following a gluten free diet, continue to have mild to moderate symptoms of gluten exposure despite the diet, have a history of biopsy proven celiac disease, and have an elevated ATG antibody level. Those meeting this criteria will then have a baseline visit which will include a short physical exam and additional lab work for safety measures, and quality of life questionnaires. They will record their diet and symptoms for 2 weeks, and then return to receive the study medication, which will be taken with all meals. The first dose will be taken in clinic to facilitate observation of any adverse effects. The next visit will be 2 weeks later for blood work and clinic visit, and then again 2 weeks later for the final visit. Participants will be prompted to report any adverse events that occur during the trial period and at the completion of the trial. During the trial period, the study coordinator will phone participants to remind them to complete their questionnaires and to inquire about adverse events. All participants will receive AGY capsules (500 mg per capsule), and will take 2 capsules with each meal.
Outcome measures The primary outcome variable will be the safety (adverse events, lab results, symptoms), which will be measured throughout the study.
The secondary outcome will be ATG antibody levels, which will be measured at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765647
|Contact: Dory Sample, MSN/MPHfirstname.lastname@example.org|
|Contact: Leo Dieleman, MD, PhDemail@example.com|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2X8|
|Contact: Dory Sample, MSN/MPH 780-248-5599 firstname.lastname@example.org|
|Contact: Leo Dieleman, MD, PhD 780-492-1888 email@example.com|
|Principal Investigator: Leo Dieleman, MD/PhD|
|Principal Investigator:||Leo Dieleman||University of Alberta|