Oral Immunotherapy for Children With Egg Allergy

Browse trials for

• Egg Hypersensitivity 34
• Food Hypersensitivity 344

Keywords

• Oral immunotherapy
• OIT
• Desensitization

Egg Hypersensitivity

34 studies on the registry are indexed under Egg Hypersensitivity; 10 are open to participants now.

This study's planned enrollment of 76 is close to the median of 76 across 23 interventional studies indexed under Egg Hypersensitivity.

Lead sponsor

Laura Ozer Kettner is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Oral immunotherapy

  Children randomized to oral immunotherapy will ingest a daily dose of raw egg. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months.

  Other: Oral immunotherapy with egg

• No intervention
  Avoidance

  Children randomized to avoidance will receive standard care for egg allergy, namely avoidance of eggs.

Interventions

• OtherOral immunotherapy with egg

  Oral immunotherapy with raw egg for 1-1.5 years

Primary outcomes

1. Tolerance to eggs (4000 mg)

   Proportion of children who tolerate a cumulative dose of 4000 mg of raw egg protein at an oral food challenge

   Time frame: 1-1.5 years after enrollment

Secondary outcomes

1. Early tolerance to eggs (4000 mg)

   Proportion of children, with a 50% or greater reduction in egg-specific immunoglobulin E (IgE) after 1 year, who tolerate a cumulative dose of 4000 mg of raw egg protein at an oral food challenge

   Time frame: 1 year after enrollment

2. Tolerance to eggs (1000 mg)

   Proportion of children who tolerate a cumulative dose of 1000 mg of raw egg protein at an oral food challenge

   Time frame: 1-1.5 years after enrollment

3. Eliciting dose

   Change in cumulative eliciting dose at an oral food challenge (mg raw egg protein)

   Time frame: At enrollment and 1-1.5 years after enrollment

4. Allergic reactions

   Proportion of children experiencing allergic reactions to eggs outside the oral food challenge, the number of reactions per child, and the severity of the reactions (World Allergy Organization grading system, grade 1-5; higher grades indicate more severe reactions)

   Time frame: 6 months, 1-1.5 years, and 2-2.5 years after enrollment

5. Use of adrenaline auto-injector

   Proportion of children for whom an adrenaline auto-injector was used due to allergic reactions to eggs outside the oral food challenge, and the number of uses per child

   Time frame: 6 months, 1-1.5 years, and 2-2.5 years after enrollment

6. Severity of allergic reactions at the oral food challenge according to the World Allergy Organization Grading System

   Severity of allergic reactions to raw eggs at the oral food challenge, graded by the World Allergy Organization grading system (grade 1-5; higher grades indicate more severe reactions)

   Time frame: 1-1.5 years after enrollment

7. Parental food allergy-related quality of life

   Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB). Total scores range from 0 to 102, with higher scores indicating worse food allergy-related quality of life

   Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment

8. Parental food allergy-related anxiety

   Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT). Total scores range from 0 to 196. Subscale scores are also reported: Cognitive subscale (range 9 to 63), Behavioral subscale (range 9 to 63), Anxiety impact (range 8 to 56), and Child coping (range 2 to 14). For all scores, higher values indicate greater food allergy-related burden.

   Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment

9. Changes in specific IgE

   Changes in egg-specific and Gal d 1 (ovomucoid)-specific IgE (kU/L)

   Time frame: At enrollment, 1-1.5 years, and 2-2.5 years after enrollment

Other outcomes

1. Characterization of allergic reactions during oral immunotherapy

   The anticipated cause, the treatment received, the timing, and whether the reaction followed a dose increase

   Time frame: During oral immunotherapy up-dosing and maintenance phase

2. Duration of oral immunotherapy up-dosing phase

   The duration of the up-dosing phase, and the reasons for deviations from the planned schedule

   Time frame: End of up-dosing phase (approximately 6 months after enrollment)

3. Study dropout

   Proportion of children who dropped out, the phase of the study at dropout, and the reasons for dropout

   Time frame: 6 months, 1-1.5 years, and 2-2.5 years after enrollment

4. Missed oral immunotherapy doses

   Proportion of missed oral immunotherapy doses, and the reasons for missed doses

   Time frame: 6 months and 1-1.5 years after enrollment

5. Long-term tolerance of egg

   Proportion of participants who still tolerate egg among those whose egg allergy resolved 1-1.5 years after enrollment

   Time frame: 2-2.5 years after enrollment

6. Frequency of egg intake

   Frequency of egg intake (daily, weekly, monthly or less than monthly) among participants whose egg allergy resolved 1-1.5 years after enrollment

   Time frame: 2-2.5 years after enrollment

7. Is oral immunotherapy worth it

   Proportion of families who considered oral immunotherapy worthwhile, and their reported key benefits and burdens

   Time frame: 1-1.5 years and 2-2.5 years after enrollment

8. Decisional conflict

   Scores on the Decisional Conflict Scale. Total scores range from 0 to 100, with higher scores indicating greater decisional conflict

   Time frame: Right after the shared decision-making process using the decision aid

9. Eosinophilic esophagitis

   Proportion of children with symptoms suggestive of eosinophilic esophagitis, and the proportion with a biopsy-confirmed diagnosis

   Time frame: 1-1.5 years after enrollment

Publications

• Cohen BL, Noone S, Munoz-Furlong A, Sicherer SH. Development of a questionnaire to measure quality of life in families with a child with food allergy. J Allergy Clin Immunol. 2004 Nov;114(5):1159-63. doi: 10.1016/j.jaci.2004.08.007. PubMed 15536425 ↗
• To S, Westwell-Roper C, Soller L, Stewart SE, Chan ES. Development of IMPAACT (Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool), a validated tool to screen for food allergy-associated parental anxiety. Ann Allergy Asthma Immunol. 2022 Oct;129(4):451-460.e3. doi: 10.1016/j.anai.2022.02.020. Epub 2022 Mar 4. PubMed 35248728 ↗
• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PubMed 7898294 ↗
• Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar. PubMed 38361745 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical and data protection considerations