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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707730

Acronym

AGY-010

Enrollment

161

Registered

2018-10-16

Start date

2019-10-29

Completion date

2023-12-31

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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.

Interventions

DIETARY_SUPPLEMENTAGY

oral AGY taken prior to meals

OTHERplacebo

oral placebo taken prior to meals

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

placebo controlled

Intervention model description

randomized double-blind, placebo-controlled crossover trial

Eligibility

Sex/Gender

ALL

Age

10 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
symptoms	14 weeks	celiac related symptoms

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026