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NCT03707730 Clinical Trial

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

Celiac Disease Clinical Trial

— AGY-010  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03707730
Other study ID # AGY-010
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 29, 2019
Est. completion date December 31, 2023

Study information
Verified date March 2024
Source Igy Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• AGY
oral AGY taken prior to meals
Other:
• placebo
oral placebo taken prior to meals

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta
Canada St Boniface Hospital Winnipeg Manitoba

Sponsors (2)
Lead Sponsor Collaborator
Igy Inc. Vetanda Group Ltd

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary symptoms celiac related symptoms 14 weeks
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