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

Phase 2

Completed

• Conditions: Celiac Disease
• Interventions: Dietary Supplement: AGY; Other: placebo

• Registration Number: NCT03707730
• Lead Sponsor: Igy Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Study Start: 2019-10-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AGY	AGY	capsule containing egg yolk with AGY
placebo	placebo	capsule containing plain egg yolk

Primary Outcome Measures

Name	Time	Method
symptoms	14 weeks	celiac related symptoms

Trial Locations

Locations (2)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

St Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada