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NCT Number: NCT03707730

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

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

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGY

Dietary Supplement

oral AGY taken prior to meals

Placebo

Other

oral placebo taken prior to meals

Primary outcomes

  1. symptoms

    Time frame: 14 weeks

    celiac related symptoms

Sponsors and collaborators

Lead sponsor

Igy Inc.

Industry

Collaborators

  • Vetanda Group Ltd

Registry information

Official study title

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

Acronym: AGY-010

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 16, 2018
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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