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CompletedPhase 2

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

Key facts

Who runs it
Igy Inc.
Where
Canada2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
161 people enrolled
Started
29 Oct 2019
Ended
31 Dec 2023
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • AGY
  • placebo
Record updated
6 March 2024

Who can take part

Age
10 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • history of CD
  • experience periodic celiac related symptoms
  • following a gluten free diet for at least 12 months

Who cannot take part

  • severe complications of CD or chronic active GI disease
  • any condition that in the opinion of the investigator, would preclude safe participation
  • type 1 diabetic
  • pregnant or breast feeding
  • daily ASA/NSAID use

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

The 2 groups in the trial

  • AGYTreatment being tested

    capsule containing egg yolk with AGY

  • placeboPlacebo, for comparison

    capsule containing plain egg yolk

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years
Record updated
6 March 2024