Soy AllergyMonsantoNCT01950559
Evaluation of Potential Allergenicity of New Soybean Varieties
An observational study of Soy Allergy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Food allergy is on the rise within the pediatric population. Having a food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Read more about this study
- Who is it for?
- Ages 6 months to 40 years
- Conditions the study is for
- Soy Allergy
- What is being tested?
- Oral food challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 15 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study population will primarily be obtained through patients at National Jewish Health
Who may be able to join
- Age 6 months to 40 years of any sex and any race
- A convincing history of allergic reaction to soybean and a positive ImmunoCAP (>0.35 kU/L) and/or a positive skin prick test to soy. Subjects should have ImmunoCAP repeated (if not done within the last 6 months) at National Jewish Health.
- One of the following:
- Recent (within one year) failed open OFC B) Positive DBPCFC to soy at NJH; or C) Recent (within one year) exposure to soybean resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing).
- Written informed consent from parent/guardian and assent (when age appropriate).
- Willingness to submit specimen for laboratory serum IgE testing
- Willingness to submit lab specimen for ELISA testing
Who cannot join
- Inability to discontinue antihistamines for skin prick testing and OFCs
- Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC
- FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma severity (Step 3 or above), and greater than high daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500 μg fluticasone or equivalents for an adult)
- Asthma requiring either:
- > 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for asthma
- History of intubation due to allergies or asthma
Show all 14Show fewer
- Life-threatening allergic reaction (i.e. respiratory compromise, hypoxia, hypotension) to food(s) within last 1 year
- Diagnosis of active eosinophilic gastrointestinal disease in the past year
- Severe or poorly controlled atopic dermatitis
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic therapy within the past year
- Uncontrolled hypertension
- Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Food allergy is on the rise within the pediatric population. Having a food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific immunoglobulin-e (IgE) testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured by the company, ThermoFisher.
Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food allergies. A part of the study is to allow the study Sponsor to use some of the blood sample collected from you to test if genetically-changed soy has more or less allergy producing factors. This is important to the Sponsor to test the safety of their genetically modified soy.
- Conditions
- Soy Allergy
- Being tested
- Oral food challenge
- Keywords
- soy allergy, food allergy, pediatric, adult
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challengeOther
Oral food challenge to determine allergy to soy
| Study group | Role | What they receive |
|---|---|---|
| Subjects who are allergic to Soy | Subject allergy to soy is determined by an oral food challenge or history of positive soy food challenge. Receives: Other: Oral food challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate soy-specific IgE antibody
To quantitatively and/or qualitatively evaluate the soy-specific IgE antibody reactivity to biotech and conventional soybean varieties using sera from clinically documented soybean-allergic subjects.
Measured: approximately 2 weeks
Secondary outcomes (2)
Relationship between IgE, components and oral food challenge
To determine the relationship between whole soy-specific IgE, IgE to components Gly m 4, 5, and 6, and OFC outcomes.
Measured: approximately 2 weeks
Monsanto repository
To establish a serum repository at Monsanto of soy-reactive allergic patients
Measured: approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion15 May 2018
- Study completion15 May 2018
Why it stopped: insufficient subjects recruited in allotted time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soy AllergyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Fleischer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950559
- Sponsor's protocol ID
- 14-0097
- Other IDs
- Monsanto
- Acronym
- Monsanto
- Status last verified
- Jul 2018
- First submitted
- 23 Sep 2013
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Allergenicity of New Soybean Varieties
- ClinicalTrials.gov ID
- NCT01950559
- Acronym / sponsor ID
- Monsanto / 14-0097
- Conditions
- Soy Allergy
- Keywords
- soy allergy, food allergy, pediatric, adult
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient subjects recruited in allotted time
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food allergy is on the rise within the pediatric population. Having a food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific immunoglobulin-e (IgE) testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured by the company, ThermoFisher.
Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food allergies. A part of the study is to allow the study Sponsor to use some of the blood sample collected from you to test if genetically-changed soy has more or less allergy producing factors. This is important to the Sponsor to test the safety of their genetically modified soy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who are allergic to Soy | – | Other: Oral food challengeSubject allergy to soy is determined by an oral food challenge or history of positive soy food challenge. |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population will primarily be obtained through patients at National Jewish Health
Key inclusion criteria (7 listed)
- Age 6 months to 40 years of any sex and any race
- A convincing history of allergic reaction to soybean and a positive ImmunoCAP (>0.35 kU/L) and/or a positive skin prick test to soy. Subjects should have ImmunoCAP repeated (if not done within the last 6 months) at National Jewish Health.
- One of the following:
- Recent (within one year) failed open OFC B) Positive DBPCFC to soy at NJH; or C) Recent (within one year) exposure to soybean resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing).
- Written informed consent from parent/guardian and assent (when age appropriate).
Key exclusion criteria (14 listed)
- Inability to discontinue antihistamines for skin prick testing and OFCs
- Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC
- FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma severity (Step 3 or above), and greater than high daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500 μg fluticasone or equivalents for an adult)
- Asthma requiring either:
- > 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for asthma
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 |
|---|---|---|
| Oral food challengeOral food challenge to determine allergy to soy | Other | Subjects who are allergic to Soy |
Primary outcome
Evaluate soy-specific IgE antibody
Time frame: approximately 2 weeks
To quantitatively and/or qualitatively evaluate the soy-specific IgE antibody reactivity to biotech and conventional soybean varieties using sera from clinically documented soybean-allergic subjects.
2 secondary outcomes
Relationship between IgE, components and oral food challenge
Time frame: approximately 2 weeks
Monsanto repository
Time frame: approximately 2 weeks
Results and safety
The study was stopped early (reason given: insufficient subjects recruited in allotted time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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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.
David Fleischer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soy Allergy, run by University of Colorado, Denver at 1 site in United States.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Jul 2018. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: insufficient subjects recruited in allotted time). Results are not available in the source record.
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?
Evaluate soy-specific IgE antibody (time frame: approximately 2 weeks). 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 Jul 2018.