Peanut AllergyIMMULITE 2000NCT01950533
The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
An observational study of Peanut Allergy and Milk Allergy, run by National Jewish Health at 1 site in United States.
Trial summary
Food allergy is on the rise within the pediatric population. Having 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 3 to 21 years
- Conditions the study is for
- Peanut Allergy, Milk Allergy, Egg Allergy
- What is being tested?
- Oral food challenge
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 29 Mar 2017
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Study population will be primarily obtained from the pediatric clinic at National Jewish Health from those suspected of egg, milk and/or peanut food allergy.
Who may be able to join
- Age 3 to 21 years of either sex and any race
- Physician-diagnosed food allergy or convincing clinical history of food allergy to milk, egg, and/or peanut AND a Skin prick test positive to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) orOR a detectable serum food-specific IgE level (ImmunoCAP and/or IMMULITE > 0.35 kUA/L) to milk, egg, and/or peanut
- If no history of clinical reactivity to milk, egg, or peanut, then a positive skin prick test to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) OR a detectable serum food-specific IgE level within the previous 4 months to milk, egg, and/or peanut
- Written informed consent from parent/guardian and assent (when age appropriate).
- Willingness to submit specimen for laboratory serum IgE 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 baseline severity (Step 3 or above), at the time of entry into the study
- Use of , and >high medium daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500500 μg/day fluticasone or equivalents for an adult) or a long acting beta-agonist (LABA) to control asthma.
- Asthma requiring either:
- > 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for asthma
Show all 20Show fewer
- History of intubation due to allergies or asthma
- Use of steroid medications (IV, IM or oral) for asthma in the following manners:
- history of daily oral steroid dosing for >1 month during the past year or
- burst or steroid course/burst in the past 3 months or
- >2 burst oral steroid courses/bursts in the past year
- History of intubation due to allergies or asthma
- Life-threatening allergic reaction (e.gi.e., respiratory compromise, hypoxia, hypotension, use of epinephrine) to study food(s) (e.g., milk, egg, and/or peanut) within last 1 year
- Diagnosis of active eosinophilic gastrointestinal disease in the past year
- Severe or poorly controlled atopic dermatitis, as assessed by a three-item severity (TIS) score of 6 or greater (see Appendix I)
- 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.
About this study
Food allergy is on the rise within the pediatric population. Having 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 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 IMMULITE 2000 manufactured by the study sponsor, Siemens.
- Conditions
- Peanut Allergy, Milk Allergy, Egg Allergy
- Being tested
- Oral food challenge
- Keywords
- Peanut allergy, Milk allergy, Egg allergy, Pediatric, Adult, Food allergy
- Medical subject headings
- Peanut Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challengeProcedure or surgery
Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.
| Study group | Role | What they receive |
|---|---|---|
| Peanut allergic | Subjects allergic to peanuts by oral food challenge Receives: Procedure: Oral food challenge | |
| Milk allergic | Subjects allergic to milk by oral food challenge Receives: Procedure: Oral food challenge | |
| Egg allergic | Subjects allergic to egg by oral food challenge Receives: Procedure: Oral food challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between food specific IgEs
To determine the relationship between food-specific IgE to whole proteins of milk, egg, and peanut using the IMMULITE 2000 assay and OFC outcomes.
Measured: approximately 2 weeks
Secondary outcomes (1)
Logisitic regression analyses on data
To compare the results of logistic regression analyses using the IMMULITE 2000 assay and food challenge outcome data to data obtained in parallel using the ImmunoCAP assay for food-specific IgE antibodies.
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 completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwin Gelfand, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950533
- Sponsor's protocol ID
- IMMULITE 2000
- Other IDs
- Siemens
- Acronym
- IMMULITE 2000
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2013
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
- ClinicalTrials.gov ID
- NCT01950533
- Acronym / sponsor ID
- IMMULITE 2000 / IMMULITE 2000
- Conditions
- Peanut Allergy, Milk Allergy, Egg Allergy
- Keywords
- Peanut allergy, Milk allergy, Egg allergy, Pediatric, Adult, Food allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (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 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 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 IMMULITE 2000 manufactured by the study sponsor, Siemens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peanut allergic | – | Procedure: Oral food challengeSubjects allergic to peanuts by oral food challenge |
| Milk allergic | – | Procedure: Oral food challengeSubjects allergic to milk by oral food challenge |
| Egg allergic | – | Procedure: Oral food challengeSubjects allergic to egg by oral food challenge |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population will be primarily obtained from the pediatric clinic at National Jewish Health from those suspected of egg, milk and/or peanut food allergy.
Key inclusion criteria (5 listed)
- Age 3 to 21 years of either sex and any race
- Physician-diagnosed food allergy or convincing clinical history of food allergy to milk, egg, and/or peanut AND a Skin prick test positive to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) orOR a detectable serum food-specific IgE level (ImmunoCAP and/or IMMULITE > 0.35 kUA/L) to milk, egg, and/or peanut
- If no history of clinical reactivity to milk, egg, or peanut, then a positive skin prick test to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) OR a detectable serum food-specific IgE level within the previous 4 months to milk, egg, and/or peanut
- Written informed consent from parent/guardian and assent (when age appropriate).
- Willingness to submit specimen for laboratory serum IgE testing
Key exclusion criteria (20 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 baseline severity (Step 3 or above), at the time of entry into the study
- Use of , and >high medium daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500500 μg/day fluticasone or equivalents for an adult) or a long acting beta-agonist (LABA) to control asthma.
- Asthma requiring either:
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 challengeConfirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge. | Procedure or surgery | Egg allergic, Milk allergic, Peanut allergic |
Primary outcome
Relationship between food specific IgEs
Time frame: approximately 2 weeks
To determine the relationship between food-specific IgE to whole proteins of milk, egg, and peanut using the IMMULITE 2000 assay and OFC outcomes.
1 secondary outcome
Logisitic regression analyses on data
Time frame: approximately 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Related trials for Peanut Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
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.
Erwin Gelfand, MD principal investigator
National Jewish Health
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 Peanut Allergy and Milk Allergy, run by National Jewish Health 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 5 inclusion and 20 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 19 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between food specific IgEs (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 19 Oct 2020.