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

March 5, 2024 updated by: Igy Inc.

A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of CD, e.g. TTG counts > 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms.

AGY is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. The study will test whether AGY is safe and effective in the study population, versus placebo.

Primary Objective: The primary objective will be to evaluate the effect of AGY on celiac symptoms using the daily Celiac Symptom Index (CSI).

Secondary objectives: Secondary objectives will be to evaluate product safety and the effect of AGY on quality of life, autoantibodies, and gut permeability.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St Boniface Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGY
capsule containing egg yolk with AGY
Dietary supplement: AGY
oral AGY taken prior to meals
Placebo Comparator: placebo
capsule containing plain egg yolk
Other: placebo
oral placebo taken prior to meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms
Time Frame: 14 weeks
celiac related symptoms
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igy Inc.

Collaborators

Vetanda Group Ltd

Investigators

  • Principal Investigator: Justine Turner, MD, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGY-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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