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Dietary Supplement

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease (AGY-010 Trial)

Phase 2
Waitlist Available
Led By Justine Turner, MD, PhD
Research Sponsored by Igy Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks

Summary

This trial is testing AGY, a treatment that neutralizes a harmful protein in gluten, in people with celiac disease who still have symptoms despite a gluten-free diet. The study aims to see if AGY can reduce symptoms and improve quality of life. Participants will be of various ages and have confirmed celiac disease. AGY is a novel egg yolk-derived antibody designed to neutralize gluten and improve the efficacy of a gluten-free diet in celiac disease patients.

Eligible Conditions
  • Celiac Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
symptoms

Side effects data

From 2015 Phase 1 trial • 10 Patients • NCT01765647
70%
conjestion or sore throat
70%
abdominal discomfort
60%
headache
40%
muscle discomfort
30%
cold symptoms
20%
eczema
20%
itchy or red eyes
10%
tiredness
10%
menstrual cramps
10%
sore ear
10%
sphincter of oddi syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
AGY: Anti-gliadin Antibody for Celiac Disease

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AGYExperimental Treatment1 Intervention
capsule containing egg yolk with AGY
Group II: placeboPlacebo Group1 Intervention
capsule containing plain egg yolk
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGY
2014
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Vetanda Group LtdUNKNOWN
VetandaUNKNOWN
Igy Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Celiac Disease
10 Patients Enrolled for Celiac Disease
Justine Turner, MD, PhDPrincipal InvestigatorUniversity of Alberta
~26 spots leftby Dec 2025
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