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, have chosen in the past to reintroduce gluten into their diet without severe adverse effects, currently follow a GFD, have a negative gluten antibody level at screening, and do not have an egg allergy. Those enrolled will receive specific amounts of gluten-containing bread and AGY capsules, to take according to a set schedule over a 16 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)|
- ATG antibody level [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]ATG will be measured at baseline, week 3 and at the end of the study period at week 16
- 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 16 week study period using the Celiac Symptom Index tool.
- Health Related Quality of Life [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]health related quality of life will be measured at 3 time points using a validated tool; baseline, week 3, and at the end of the study at week 16
- General Safety [ Time Frame: duration of the study, up to 16 weeks ] [ Designated as safety issue: Yes ]Safety will be evaluated by physical exams, laboratory tests, and adverse event monitoring, at baseline, week 3 and at the end of the study at week 16. In the event of serious symptom development, participants will be asked to return to clinic as soon as possible for an evaluation.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
All participants will receive the same, open-label dose of AGY and a corresponding set "dose" of bread (with a known amount of gluten).
AGY is a natural health product produced in egg yolks
The trial will begin on the day that subjects start on the first day and end 16 weeks later. All outcomes will be measured at baseline (Day 0) and at the end of the trial period (week 16). The first dose will be taken in clinic, to facilitate observation of any adverse effects. The study coordinator will phone participants on the day(s) leading up to their assessments to remind them to complete their questionnaires and ensure they remain comfortable with the study procedures. The primary outcome (ATG antibody levels in the blood) and one secondary outcome (HLQOL) will be measured again at week 3; symptoms will be measured daily. Subjects 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 every 2 weeks to remind them to complete their questionnaires and to inquire about adverse events All participants will be assigned to receive 1 slice of gluten-containing bread (5 g per slice) and AGY capsule (1000 mg per capsule) (no "placebo" bread and no "placebo" capsule). The same dose of bread and AGY will be continued for 1 week, followed by 1 week of a wash-out period. The "dose" of bread will increase by one slice every second week, until the subjects will eat 8 slices of bread a day (a total of 40 g gluten) by week 15 of the study, along with 8 capsules of AGY.
Outcome measures The primary outcome variable will be the ATG level. This measure will indicate the efficacy of AGY while a gluten containing food is regularly consumed. The measure will be assessed at baseline, week 3, and at study end at week 16.
Secondary outcomes include health related quality of life, Celiac symptom index, and adverse events.
|Contact: Dory Sample, MSN/MPHemail@example.com|
|Contact: Leo Dieleman, MD, PhDfirstname.lastname@example.org|
|University of Alberta||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2X8|
|Contact: Dory Sample, MSN/MPH 780-248-5599 email@example.com|
|Contact: Leo Dieleman, MD, PhD 780-492-1888 firstname.lastname@example.org|
|Principal Investigator: Leo Dieleman, MD/PhD|
|Principal Investigator:||Leo Dieleman||University of Alberta|