NCT03707730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

October 29, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4.2 years

First QC Date

October 12, 2018

Last Update Submit

March 5, 2024

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • symptoms

    celiac related symptoms

    14 weeks

Study Arms (2)

AGY

EXPERIMENTAL

capsule containing egg yolk with AGY

Dietary Supplement: AGY

placebo

PLACEBO COMPARATOR

capsule containing plain egg yolk

Other: placebo

Interventions

AGYDIETARY_SUPPLEMENT

oral AGY taken prior to meals

AGY
placeboOTHER

oral placebo taken prior to meals

placebo

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • history of CD
  • experience periodic celiac related symptoms
  • following a gluten free diet for at least 12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

St Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Justine Turner, MD, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
placebo controlled
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: randomized double-blind, placebo-controlled crossover trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

October 29, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)