Trial Outcomes & Findings for Oral AGY for Celiac Disease (NCT NCT01765647)

NCT ID: NCT01765647

Last Updated: 2019-12-13

Results Overview

Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: week 6
• Results posted on: 2019-12-13

Participant Flow

Participant milestones

Measure	AGY: Anti-gliadin Antibody for Celiac Disease All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral AGY for Celiac Disease

Baseline characteristics by cohort

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 Participants All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=113 Participants
Age, Categorical >=65 years	1 Participants n=113 Participants
Age, Continuous	43.4 years n=113 Participants
Sex: Female, Male Female	9 Participants n=113 Participants
Sex: Female, Male Male	1 Participants n=113 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=113 Participants
Region of Enrollment Canada	10 participants n=113 Participants

PRIMARY outcome

Timeframe: week 6

Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results

Outcome measures

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 Participants All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
Number of Participants for Which Treatment Was Concluded to be Safe mild adverse events during run-in	6 participants
Number of Participants for Which Treatment Was Concluded to be Safe moderate adverse events during run-in	18 participants
Number of Participants for Which Treatment Was Concluded to be Safe severe adverse events during run-in	4 participants
Number of Participants for Which Treatment Was Concluded to be Safe mild adverse events on tx week 2-4	5 participants
Number of Participants for Which Treatment Was Concluded to be Safe moderate adverse events on tx week 2-4	11 participants
Number of Participants for Which Treatment Was Concluded to be Safe severe adverse events on tx week 2-4	2 participants
Number of Participants for Which Treatment Was Concluded to be Safe mild adverse events on tx week 4-6	5 participants
Number of Participants for Which Treatment Was Concluded to be Safe moderate adverse events on tx week 4-6	1 participants
Number of Participants for Which Treatment Was Concluded to be Safe severe adverse events on tx week 4-6	3 participants
Number of Participants for Which Treatment Was Concluded to be Safe serious adverse events at any time	0 participants
Number of Participants for Which Treatment Was Concluded to be Safe withdrawal due to adverse event at any time	0 participants
Number of Participants for Which Treatment Was Concluded to be Safe all cause mortality	0 participants

SECONDARY outcome

Timeframe: daily for 6 weeks

Symptoms of Celiac disease will be self-measured by participants daily for the entire 6 week study period using the Celiac Symptom Index tool.

Outcome measures

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 Participants All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
Number Celiac Disease Related Symptoms in Participants tiredness during 2 weeks of run-in	93 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants tiredness during last 2 weeks on AGY	52 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants headache during 2 weeks of run-in	59 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants headache during last 2 weeks on AGY	39 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants abdominal pain/discomfort during 2 weeks of run-in	48 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants abdominal pain/discomfort during last 2 weeks on A	39 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants bloating during 2 weeks of run-in	45 Number of Celiac Disease Related Symptom
Number Celiac Disease Related Symptoms in Participants bloating during last 2 weeks on AGY	26 Number of Celiac Disease Related Symptom

SECONDARY outcome

Timeframe: week 6

Population: Scores were assessed at baseline, week 2, week 4 and week 6; baseline and week 6 reported.

health related quality of life will be measured at 4 time points using a validated tool; (short form 36; SF-36) baseline, week 2, week 4, and at the end of the study at week 6.

Scores can range from 20-80, with 50 being a population norm. Therefore, a score above 50 indicates better than the general population norm, and a score below 50 indicates worse than the population norm.

Outcome measures

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 Participants All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
Health Related Quality of Life baseline physical component summary	50.08 score on a scale Interval 20.0 to 80.0
Health Related Quality of Life week 6 physical component summary	51.77 score on a scale Interval 20.0 to 80.0
Health Related Quality of Life baseline mental component summary	49.34 score on a scale Interval 20.0 to 80.0
Health Related Quality of Life week 6 mental component summary	52.12 score on a scale Interval 20.0 to 80.0

SECONDARY outcome

Timeframe: screening through final visit

The ATG antibody level will be measured at baseline, week 2, week 4 and week 6. Normal values are less than 7; elevated values mean a worse outcome. Assessed at baseline, week 2, week 4 and week 6; baseline and week 6 reported.

Outcome measures

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 Participants All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
ATG Antibody Level baseline IgA TTG	1.538 U/mL Standard Deviation 1.128
ATG Antibody Level week 6 IgA TTG	0.922 U/mL Standard Deviation 0.606

Adverse Events

AGY: Anti-gliadin Antibody for Celiac Disease

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AGY: Anti-gliadin Antibody for Celiac Disease n=10 participants at risk All participants will receive the same, open-label dose of AGY AGY: AGY is a natural health product produced in egg yolks
General disorders tiredness	10.0% 1/10
Gastrointestinal disorders abdominal discomfort	70.0% 7/10
Ear and labyrinth disorders sore ear	10.0% 1/10
Eye disorders itchy or red eyes	20.0% 2/10
Hepatobiliary disorders sphincter of oddi syndrome	10.0% 1/10
Infections and infestations cold symptoms	30.0% 3/10
Musculoskeletal and connective tissue disorders muscle discomfort	40.0% 4/10
Nervous system disorders headache	60.0% 6/10
Reproductive system and breast disorders menstrual cramps	10.0% 1/10
Respiratory, thoracic and mediastinal disorders conjestion or sore throat	70.0% 7/10
Skin and subcutaneous tissue disorders eczema	20.0% 2/10

Additional Information

Dory Sample

University of Alberta

Phone: 780-248-5599

Email: dory.sample@ahs.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place