Egg HypersensitivityNCT01489553
Egg Oral Immunotherapy
An observational study of Egg Hypersensitivity, run by Children's Hospital of Philadelphia.
Trial summary
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of children (its prevalence is higher in children with… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Egg Hypersensitivity
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2013
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: outpatient Allergy patients followed at The Children's Hospital of Philadelphia
Who may be able to join
- Subjects must satisfy all inclusion criteria:
- Subjects must be age six to 17 years and have a history of egg allergy. Subjects shall maintain strict avoidance of consumption of all egg protein containing foods.
- Subjects will have a history (within the past six months) of a positive skin prick test to egg extract or an immunocap IgE level greater than 0.35 kU/L, and a positive allergic reaction history to egg within the past 12 months.
- Subjects will be accepted to the study if they have had a positive food challenge conducted at CHOP in the three months prior to the start of the study.
- Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- If a positive pregnancy test was obtained during the study, the subject will be asked to withdraw from the study.
- Informed consent of parent or legal guardian is required.
Who cannot join
- Subjects will be excluded from the study if they meet any one of the following criteria:
- Ability to tolerate baked goods containing egg or the ability to tolerate a serving size of egg (6.3 grams of egg protein.)
- Pregnancy.
- A history of food protein induced enterocolitis syndrome to egg.
- A history of eosinophilic esophagitis, where egg has been identified as a causative food.
- A history of anaphylaxis requiring overnight hospitalization.
Show all 19Show fewer
- A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management.
- A current diagnosis of severe persistent asthma [FEV1 (forced expiratory volume in 1 second) < 60% of predicted, as defined by NHLBI (National Heart, Lung, and Blood Institute) guidelines, despite current therapy].
- A current diagnosis of severe atopic dermatitis.
- A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- Use of oral or injection steroids within one month of protocol initial visit.
- Should it become necessary for a subject to be on systemic corticosteroids while on the study, the subject will either be withdrawn from the study or the use of corticosteroids during the study will be taken into account during data analysis. The PI and lead investigators will make that decision based on the individual case.
- An acute illness within one week prior to the first dose of oral immunotherapy.
- Use of antihistamines within three days prior to Double blind placebo-controlled food challenge (DBPCFC).
- Use of chronic immunomodulatory therapy.
- Participation in another experimental therapy study.
- Participation in a study for the treatment of food allergy in the past 12 months.
- Inability to discontinue antihistamines for skin testing and food challenges.
- A positive pregnancy test.
About this study
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of children (its prevalence is higher in children with atopic dermatitis or other food allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to investigate the safety and efficacy of baked egg oral immunotherapy.
Read the detailed description
The primary objective is to study the efficacy of baked egg oral immunotherapy. The secondary objectives are to determine the safety of allergen-specific immunotherapy for egg allergy through ingestion of baked egg products and whether it will ultimately lead to a desensitized state for native egg. We will also examine if quality of life is improved by expansion of diets.
Subjects aged six to 17 years with a history of egg protein allergy will be recruited from The Children's Hospital of Philadelphia (CHOP) Allergy practice (main campus and satellite locations).
Prior to and after the desensitization to baked egg, we will conduct double blind placebo-controlled food challenges to native egg protein. During the desensitization phase, we will give increasing doses of baked egg (meringue cookie or equivalent) on a weekly basis, as tolerated.
The primary endpoint of the study includes the percentage of subjects who can successfully complete the food challenge to native egg once they have completed the desensitization protocol to baked egg. Secondary outcome measures include egg-specific IgE, quality of life before and after desensitization, and egg skin prick test size.
- Conditions
- Egg Hypersensitivity
- Keywords
- Egg hypersensitivity, egg allergy, egg protein allergy
- Medical subject headings
- Egg Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children completing desensitization
Evaluate proportion of subjects who successfully complete the food challenge to native egg upon completion of the desensitization protocol to baked egg.
Measured: Baseline & 12 months
Secondary outcomes (3)
Change in Egg specific IgE values at the beginning and end of desensitization
Specific IgE values will be compared for egg at the beginning and the end of the desensitization protocol.
Measured: Baseline & 12 months
Change in quality of life variables
Comparison of quality of life before and after desensitization through the completion of a voluntary and confidential survey.
Measured: Baseline & 12 months
Number of participants with adverse events
Determine the safety of allergen-specific immunotherapy for egg allergy through ingestion of baked egg products and whether it will ultimately lead to a desensitized state for native egg.
Measured: Baseline & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg HypersensitivityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan M. Spergel, MD, PhD, Principal investigator, Children's Hospital of PhiladelphiaRushani W. Saltzman, MD, Study director, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489553
- Sponsor's protocol ID
- IRB 11-008294
- Status last verified
- Oct 2012
- First submitted
- 8 Dec 2011
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Oral Immunotherapy
- ClinicalTrials.gov ID
- NCT01489553
- Acronym / sponsor ID
- IRB 11-008294
- Conditions
- Egg Hypersensitivity
- Keywords
- Egg hypersensitivity, egg allergy, egg protein allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Dec 2011 (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.
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of children (its prevalence is higher in children with atopic dermatitis or other food allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to investigate the safety and efficacy of baked egg oral immunotherapy.
Detailed description
The primary objective is to study the efficacy of baked egg oral immunotherapy. The secondary objectives are to determine the safety of allergen-specific immunotherapy for egg allergy through ingestion of baked egg products and whether it will ultimately lead to a desensitized state for native egg. We will also examine if quality of life is improved by expansion of diets.
Subjects aged six to 17 years with a history of egg protein allergy will be recruited from The Children's Hospital of Philadelphia (CHOP) Allergy practice (main campus and satellite locations).
Prior to and after the desensitization to baked egg, we will conduct double blind placebo-controlled food challenges to native egg protein. During the desensitization phase, we will give increasing doses of baked egg (meringue cookie or equivalent) on a weekly basis, as tolerated.
The primary endpoint of the study includes the percentage of subjects who can successfully complete the food challenge to native egg once they have completed the desensitization protocol to baked egg. Secondary outcome measures include egg-specific IgE, quality of life before and after desensitization, and egg skin prick test size.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- outpatient Allergy patients followed at The Children's Hospital of Philadelphia
Key inclusion criteria (8 listed)
- Subjects must be age six to 17 years and have a history of egg allergy. Subjects shall maintain strict avoidance of consumption of all egg protein containing foods.
- Subjects will have a history (within the past six months) of a positive skin prick test to egg extract or an immunocap IgE level greater than 0.35 kU/L, and a positive allergic reaction history to egg within the past 12 months.
- Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- If a positive pregnancy test was obtained during the study, the subject will be asked to withdraw from the study.
Key exclusion criteria (19 listed)
- Ability to tolerate baked goods containing egg or the ability to tolerate a serving size of egg (6.3 grams of egg protein.)
- Pregnancy.
- A history of food protein induced enterocolitis syndrome to egg.
- A history of eosinophilic esophagitis, where egg has been identified as a causative food.
- A history of anaphylaxis requiring overnight hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of children completing desensitization
Time frame: Baseline & 12 months
Evaluate proportion of subjects who successfully complete the food challenge to native egg upon completion of the desensitization protocol to baked egg.
3 secondary outcomes
Change in Egg specific IgE values at the beginning and end of desensitization
Time frame: Baseline & 12 months
Change in quality of life variables
Time frame: Baseline & 12 months
Number of participants with adverse events
Time frame: Baseline & 12 months
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 22 Oct 2013.
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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.
Jonathan M. Spergel, MD, PhD principal investigator
Children's Hospital of Philadelphia
Rushani W. Saltzman, MD study director
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
An observational study of Egg Hypersensitivity, run by Children's Hospital of Philadelphia.
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 8 inclusion and 19 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 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of children completing desensitization (time frame: Baseline & 12 months). 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 22 Oct 2013.