A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease (AGY-010)
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|ClinicalTrials.gov Identifier: NCT03707730|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease||Dietary Supplement: AGY Other: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||149 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||randomized double-blind, placebo-controlled crossover trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||placebo controlled|
|Official Title:||A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years|
|Actual Study Start Date :||October 29, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
capsule containing egg yolk with AGY
Dietary Supplement: AGY
oral AGY taken prior to meals
Placebo Comparator: placebo
capsule containing plain egg yolk
oral placebo taken prior to meals
- symptoms [ Time Frame: 14 weeks ]celiac related symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707730
|Contact: Dory Sample, MSN, MPHfirstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 1C9|
|Contact: Dory Sample, MSN, MPH 780-248-5599 email@example.com|
|Principal Investigator: Justine Turner, MD, PhD|
|Sub-Investigator: Leo Dieleman, MD, PhD|
|Principal Investigator:||Justine Turner, MD, PhD||University of Alberta|