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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707730
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Vetanda
Information provided by (Responsible Party):
Igy Inc.

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

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: AGY Other: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: AGY
capsule containing egg yolk with AGY
Dietary Supplement: AGY
oral AGY taken prior to meals

Placebo Comparator: placebo
capsule containing plain egg yolk
Other: placebo
oral placebo taken prior to meals




Primary Outcome Measures :
  1. symptoms [ Time Frame: 14 weeks ]
    celiac related symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Dory Sample, MSN, MPH 780-248-5599 dory.sample@ahs.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Contact: Dory Sample, MSN, MPH    780-248-5599    dory.sample@ahs.ca   
Principal Investigator: Justine Turner, MD, PhD         
Sub-Investigator: Leo Dieleman, MD, PhD         
Sponsors and Collaborators
Igy Inc.
Vetanda
Investigators
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Principal Investigator: Justine Turner, MD, PhD University of Alberta
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Responsible Party: Igy Inc.
ClinicalTrials.gov Identifier: NCT03707730    
Other Study ID Numbers: AGY-010
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases