Oral AGY for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      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,
      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. 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.
    

Detailed description: 
      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, and have a history of biopsy proven celiac disease. 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.
    

Intervention name(s): AGY
Intervention type(s): Other
Intervention description(s): AGY is a natural health product produced in egg yolks
Intervention model: Single Group Assignment
Intervention model description: All participants received open label AGY, a natural health product
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Celiac disease; AGY