Celiac DiseasePhase 1NCT01765647
Oral AGY for Celiac Disease
A Phase 1 study testing AGY in people with Celiac Disease, run by Igy Inc. at 1 site in Canada.
Trial summary
Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of the small intestine to gluten causes an inflammatory response, leading to the destruction of intestine lining, often with severe… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- AGY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Aug 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or over
- confirmed diagnosis of Celiac disease by previous biopsy
- follow a gluten-free diet (GFD)
- have mild to moderate symptoms despite the GFD diet
Who cannot join
- diabetic
- use of steroids in previous year
- current use of ASA/NSAIDs, metronidazole, or misoprostol
- excess alcohol intake
- egg allergy
- history of severe complications of celiac disease or chronic active GI disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of an Orally Administered Antibody to Gluten to Prevent the Recurrence of Symptoms and Laboratory Parameters in Persons With Celiac Disease (Gluten Sensitive Enteropathy)
Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of the small intestine to gluten causes an inflammatory response, leading to the destruction of intestine lining, often with severe symptoms including diarrhea, abdominal distention, fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the only treatment currently available is strict adherence to a life-time gluten free diet (GFD). However, adhering to this diet is difficult as gluten proteins are found in many food products. Therefore, the gluten-free diet has both lifestyle and financial implications for the individual and thus has been potential for impacting adversely on their quality of life.
Various approaches are being studied to reduce the need for careful control of the diet for those with CD, including the use of antibodies such as IgY. IgY is produced from the egg yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal toxicity, for those without egg allergy, and offer low-cost, hygienic production of study product. Once the IgY antibody is put into capsule form, it is called AGY.
Individuals with CD will be recruited only if they have a history of biopsy proven CD, currently follow a GFD but continue to have mild to moderate symptoms related to gluten exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at screening. Those enrolled will have a 2 week run-in period where diet and symptoms are recorded, and will then receive AGY capsules to take with meals over a 4 week period. Outcomes will be measured by examining lab test results including antibody levels, symptoms, and quality of life.
Read the detailed description
The trial will last approximately 6 weeks. Individuals will be screened to ensure they are following a gluten free diet, continue to have mild to moderate symptoms of gluten exposure despite the diet, and have a history of biopsy proven celiac disease. Those meeting this criteria will then have a baseline visit which will include a short physical exam and additional lab work for safety measures, and quality of life questionnaires. They will record their diet and symptoms for 2 weeks, and then return to receive the study medication, which will be taken with all meals. The first dose will be taken in clinic to facilitate observation of any adverse effects. The next visit will be 2 weeks later for blood work and clinic visit, and then again 2 weeks later for the final visit. Participants will be prompted to report any adverse events that occur during the trial period and at the completion of the trial. During the trial period, the study coordinator will phone participants to remind them to complete their questionnaires and to inquire about adverse events. All participants will receive AGY capsules (500 mg per capsule), and will take 2 capsules with each meal.
Outcome measures The primary outcome variable will be the safety (adverse events, lab results, symptoms), which will be measured throughout the study.
The secondary outcome will be ATG antibody levels, which will be measured at each visit.
- Conditions
- Celiac Disease
- Being tested
- AGY
- Keywords
- Celiac disease, AGY
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGYOther
AGY is a natural health product produced in egg yolks
| Study group | Role | What they receive |
|---|---|---|
| AGY | Experimental | All participants will receive the same, open-label dose of AGY Receives: Other: AGY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for Which Treatment Was Concluded to be Safe
Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results
Measured: week 6
Secondary outcomes (3)
Number Celiac Disease Related Symptoms in Participants
Symptoms of Celiac disease will be self-measured by participants daily for the entire 6 week study period using the Celiac Symptom Index tool.
Measured: daily for 6 weeks
Health Related Quality of Life
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.
Measured: week 6
ATG Antibody Level
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.
Measured: screening through final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received open label AGY, a natural health product
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igy Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
- Investigators
- Leo Dieleman, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765647
- Sponsor's protocol ID
- AGY
- Status last verified
- Oct 2019
- First submitted
- 8 Jan 2013
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Orally Administered Antibody to Gluten to Prevent the Recurrence of Symptoms and Laboratory Parameters in Persons With Celiac Disease (Gluten Sensitive Enteropathy)
- ClinicalTrials.gov ID
- NCT01765647
- Acronym / sponsor ID
- AGY
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, AGY
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Igy Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of the small intestine to gluten causes an inflammatory response, leading to the destruction of intestine lining, often with severe symptoms including diarrhea, abdominal distention, fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the only treatment currently available is strict adherence to a life-time gluten free diet (GFD). However, adhering to this diet is difficult as gluten proteins are found in many food products. Therefore, the gluten-free diet has both lifestyle and financial implications for the individual and thus has been potential for impacting adversely on their quality of life.
Various approaches are being studied to reduce the need for careful control of the diet for those with CD, including the use of antibodies such as IgY. IgY is produced from the egg yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal toxicity, for those without egg allergy, and offer low-cost, hygienic production of study product. Once the IgY antibody is put into capsule form, it is called AGY.
Individuals with CD will be recruited only if they have a history of biopsy proven CD, currently follow a GFD but continue to have mild to moderate symptoms related to gluten exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at screening. Those enrolled will have a 2 week run-in period where diet and symptoms are recorded, and will then receive AGY capsules to take with meals over a 4 week period. Outcomes will be measured by examining lab test results including antibody levels, symptoms, and quality of life.
Detailed description
The trial will last approximately 6 weeks. Individuals will be screened to ensure they are following a gluten free diet, continue to have mild to moderate symptoms of gluten exposure despite the diet, and have a history of biopsy proven celiac disease. Those meeting this criteria will then have a baseline visit which will include a short physical exam and additional lab work for safety measures, and quality of life questionnaires. They will record their diet and symptoms for 2 weeks, and then return to receive the study medication, which will be taken with all meals. The first dose will be taken in clinic to facilitate observation of any adverse effects. The next visit will be 2 weeks later for blood work and clinic visit, and then again 2 weeks later for the final visit. Participants will be prompted to report any adverse events that occur during the trial period and at the completion of the trial. During the trial period, the study coordinator will phone participants to remind them to complete their questionnaires and to inquire about adverse events. All participants will receive AGY capsules (500 mg per capsule), and will take 2 capsules with each meal.
Outcome measures The primary outcome variable will be the safety (adverse events, lab results, symptoms), which will be measured throughout the study.
The secondary outcome will be ATG antibody levels, which will be measured at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received open label AGY, a natural health product
| Arm | Type | Receives |
|---|---|---|
| AGY | Experimental | Other: AGYAll participants will receive the same, open-label dose of AGY |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or over
- confirmed diagnosis of Celiac disease by previous biopsy
- follow a gluten-free diet (GFD)
- have mild to moderate symptoms despite the GFD diet
Key exclusion criteria (7 listed)
- diabetic
- use of steroids in previous year
- current use of ASA/NSAIDs, metronidazole, or misoprostol
- excess alcohol intake
- egg allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGYAGY is a natural health product produced in egg yolks | Other | AGY |
Primary outcome
Number of Participants for Which Treatment Was Concluded to be Safe
Time frame: week 6
Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results
3 secondary outcomes
Number Celiac Disease Related Symptoms in Participants
Time frame: daily for 6 weeks
Health Related Quality of Life
Time frame: week 6
ATG Antibody Level
Time frame: screening through final visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo Dieleman principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGY in people with Celiac Disease, run by Igy Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Which Treatment Was Concluded to be Safe (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.