NCT07895095|Not Yet Recruiting
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Sponsor study identifier
interventional
56
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 peanut allergy tolerate peanut. Children aged 6 months to 4 years can take part in the trial. Main question: What percentage of children can tolerate peanut after oral immunotherapy, compared with children who avoid peanut? 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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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 26, 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 peanut (4000 mg)
Proportion of children who tolerate a cumulative dose of 4000 mg of peanut protein at an oral food challenge
1-1.5 years after enrollment
Tolerance to peanut (1000 mg)
1-1.5 years after enrollment
Eliciting dose
At enrollment and 1-1.5 years after enrollment
Children randomized to oral immunotherapy will ingest a daily dose of peanut. 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 peanut allergy, namely avoidance of peanut.
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
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.
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.
Laura O Kettner, MD, PhD
The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
First Submitted
September 28, 2026
First Posted
October 26, 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 Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Tolerance in Hong Kong Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
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
Severity of allergic reactions at the oral food challenge according to the World Allergy Organization Grading System
1-1.5 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
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.
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
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 26, 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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