A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Celiac Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: randomized double-blind, placebo-controlled crossover trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: placebo controlledPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 10 years and 65 years
- Gender
- Both males and females
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,...
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.
Tracking Information
- NCT #
- NCT03707730
- Collaborators
- Vetanda
- Investigators
- Principal Investigator: Justine Turner, MD, PhD University of Alberta
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