NCT07888439|Not Yet Recruiting
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Sponsor study identifier
interventional
76
1 country
5
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This clinical trial aims to investigate if oral immunotherapy can help children with egg allergy tolerate eggs. Children aged 6-18 months can take part in the trial. Main question: What percentage of children can tolerate eggs after oral immunotherapy, compared with children who avoid eggs? Children are assigned to these two groups by chance. Children receiving oral immunotherapy will:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 22, 2026
Actual (reported)October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
1-1.5 years after enrollment
Early tolerance to eggs (4000 mg)
1 year after enrollment
Tolerance to eggs (1000 mg)
1-1.5 years after enrollment
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.
Children randomized to avoidance will receive standard care for egg allergy, namely avoidance of eggs.
Oral immunotherapy with raw egg for 1-1.5 years
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Denmark
Regional Hospital Gødstrup
Gødstrup, Denmark
Regional Hospital Kolding
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.
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.
Laura O Kettner, MD, PhD
The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
First Submitted
September 28, 2026
First Posted
October 22, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2030
A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy
Eliciting dose
At enrollment and 1-1.5 years after enrollment
Allergic reactions
6 months, 1-1.5 years, and 2-2.5 years after enrollment
Use of adrenaline auto-injector
6 months, 1-1.5 years, and 2-2.5 years after enrollment
Characterization of allergic reactions during oral immunotherapy
During oral immunotherapy up-dosing and maintenance phase
Duration of oral immunotherapy up-dosing phase
End of up-dosing phase (approximately 6 months after enrollment)
Study dropout
6 months, 1-1.5 years, and 2-2.5 years after enrollment
Contact the study team to confirm eligibility.
Kolding, Denmark
Regional Hospital Randers
Randers, Denmark
Regional Hospital Viborg
Viborg, Denmark
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
Individual participant data will not be shared due to ethical and data protection considerations
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Source: ClinicalTrials.gov.
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