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

Igy Inc.

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Other: placebo; Dietary Supplement: AGY

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03707730

AGY-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups, including a placebo group

AGY

Experimental group

Description:

capsule containing egg yolk with AGY

Treatment:

Dietary Supplement: AGY

placebo

Placebo Comparator group

Description:

capsule containing plain egg yolk

Treatment:

Other: placebo