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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized double-blind, placebo-controlled crossover trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

placebo controlled

Study Groups

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AGY

capsule containing egg yolk with AGY

Group Type EXPERIMENTAL

AGY

Intervention Type DIETARY_SUPPLEMENT

oral AGY taken prior to meals

placebo

capsule containing plain egg yolk

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

oral placebo taken prior to meals

Interventions

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AGY

oral AGY taken prior to meals

Intervention Type DIETARY_SUPPLEMENT

placebo

oral placebo taken prior to meals

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No