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

Study Purpose

To assess the efficacy and safety of AGY vs.#46;placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 10 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03707730
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Igy Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Justine Turner, MD, PhD
Principal Investigator Affiliation University of Alberta
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

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.

Contact a Trial Team

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International Sites

University of Alberta, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta

Edmonton, Alberta, T6G 1C9

Site Contact

Dory Sample, MSN, MPH

dory.sample@ahs.ca

780-248-5599

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