An interventional study of Peanut Oral Immunotherapy (OIT) in Food Allergy in Children and Food Allergy Peanut, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.
This is an open-label, non-randomized, two-arm trial designed to evaluate the real-world efficacy, safety, and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol for children under 18 in Hong Kong. The study addresses a significant unmet need by providing access to a treatment available overseas and aims to establish a translatable model for future food allergy treatments in the region. The intervention arm (n=100) will undergo 18 months of peanut OIT, while the control arm (n=25) will follow standard care, i.e., strict peanut avoidance for the same duration.
Eligible children aged 2-17 with a confirmed peanut allergy will be recruited from the Specialist Outpatient Clinic at the Prince of Wales Hospital and through referral from other public hospitals. Participants will be allocated to the active or control arm in a 4:1 ratio.
The primary efficacy measure is the proportion of participants in the OIT group versus the control group who achieve a desensitization level of more than 640 mg of peanut protein, as confirmed by an oral food challenge at the end of the 18-month treatment period.
Some of the key secondary objectives include to systematically document the frequency and severity of treatment-related adverse events and the proportion of participants discontinuing OIT due to these events; and to identify distinct pre- and post-treatment plasma protein biomarkers associated with successful OIT.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 125 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrolment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Peanut Oral Immunotherapy (OIT)
This study uses a commercially available, standardized defatted peanut powder as its active intervention
Desensitization Rate at EOT
Proportion of participants with a peanut eliciting dose \>640 mg protein at end-of-treatment (EOT) in OIT vs control groups.
Time frame: EOT (18 months)
Safety During Treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in active vs control group
Time frame: Baseline to EOT (18 months)
Plan to share: Undecided — The potential sharing of IPD is currently under careful consideration by the institutional review board and research ethics committee. A final decision will depend on several factors, including: 1) compliance with local data protection regulations and institutional policies in Hong Kong, 2) ensuring adequate de-identification of participant data given the relatively small and potentially identifiable patient population, and 3) alignment with the specific consent obtained from participants regarding data sharing. We are committed to responsible data stewardship while maximizing the scientific value of this research, and will make a definitive determination before study completion.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2028, 37 months after the start.
Of 20 interventional studies with no phase under Peanut Hypersensitivity, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
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Chinese University of Hong Kong →