Egg Oral Immunotherapy

NCT01489553 | Completed DMC

• 1 other identifier: IRB 11-008294
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Egg Hypersensitivity

Keywords

Egg hypersensitivity; egg allergy; egg protein allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline & 12 months

Secondary Outcomes (3)

• Change in Egg specific IgE values at the beginning and end of desensitization

  Baseline & 12 months

• Change in quality of life variables

  Baseline & 12 months

• Number of participants with adverse events

  Baseline & 12 months

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

outpatient Allergy patients followed at The Children's Hospital of Philadelphia

You may qualify if:

• 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.
• a. 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.

You may not qualify if:

• 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.
• 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.
• a. 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunocap testing (bloodwork) will be performed prior to and upon completion of the desensitization protocol. This testing is considered standard of care in the management of food allergies.

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jonathan M. Spergel, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Rushani W. Saltzman, MD

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 22, 2013

Record last verified: 2012-10