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

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    149
  • sponsor
    Igy Inc.
Updated on 15 February 2022
gluten

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.

Details
Condition Celiac Disease
Treatment Placebo, AGY
Clinical Study IdentifierNCT03707730
SponsorIgy Inc.
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

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
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