AGY for Celiac Disease
(AGY-010 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AGY, a capsule made from egg yolk, to determine if it alleviates symptoms in people with celiac disease while remaining safe. Celiac disease causes uncomfortable symptoms when gluten is consumed. The trial compares AGY with a placebo, a similar-looking capsule without the active ingredient. It seeks participants diagnosed with celiac disease who continue to experience symptoms despite following a gluten-free diet for at least a year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use ASA (aspirin) or NSAIDs (non-steroidal anti-inflammatory drugs) daily.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has mostly studied AGY in birds, where treatment involved amphotericin B, a medicine that fights fungal infections. This suggests a possible link between AGY and fungal infections. However, clear information on how humans handle AGY is lacking.
This is a Phase 2 trial, indicating that earlier studies have already tested AGY for safety in a small group of people. The current goal is to learn more about its safety in a larger group. If AGY were unsafe, it likely wouldn't have reached this stage. However, like any treatment, side effects may still occur.
Prospective participants should discuss any concerns with the trial team to understand the possible risks and benefits.12345Why do researchers think this study treatment might be promising for CD?
Unlike most treatments for celiac disease, which often involve strict dietary restrictions to avoid gluten, AGY offers a novel approach by using a capsule containing egg yolk with the active ingredient AGY. Researchers are excited about AGY because it has a unique mechanism that may help protect the intestines from gluten damage, potentially reducing symptoms and allowing more dietary flexibility. This is a significant shift from just managing symptoms to possibly preventing the underlying damage caused by gluten exposure, which could improve quality of life for those with celiac disease.
What evidence suggests that AGY might be an effective treatment for CD?
Research has shown that AGY, an antibody from egg yolks, might assist people with celiac disease who adhere to a gluten-free diet. In this trial, some participants will receive AGY, which earlier studies found to be safe and possibly linked to improvements in celiac disease symptoms. Specifically, those taking AGY experienced fewer symptoms while maintaining their gluten-free diet. Although further research is necessary to confirm these results, initial findings suggest AGY could be a promising option for managing celiac disease symptoms.678910
Who Is on the Research Team?
Justine Turner, MD, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AGY or placebo in a double-blind, crossover design to evaluate efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGY
- placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Igy Inc.
Lead Sponsor
Vetanda Group Ltd
Collaborator
Vetanda
Collaborator