Fish allergy cure? new trial tests codfish therapy in kids
NCT ID NCT05590299
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving children with fish allergy small, increasing doses of codfish protein (oral immunotherapy) can help them tolerate fish without reactions. 70 children aged 2 to 10 will receive either codfish or a placebo for 12 months, then be tested for desensitisation and sustained unresponsiveness. The goal is to reduce the risk of accidental allergic reactions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- codfish protein (oral immunotherapy)
- What this could lead to
- If it works, this could offer a way for children with fish allergy to safely eat fish without severe reactions, reducing fear of accidental exposure.
- What could go wrong
- This is an early-stage trial with only 70 children, so results may not apply to everyone. Oral immunotherapy can cause allergic reactions during treatment, and long-term tolerance is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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70 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 10 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged between 2 year and 10 years of age * \>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext) * Confirmed diagnosis of codfish allergy as defined by a failed DBPCFC with codfish and a positive SPT (\>=3mm than control) or sIgE to codfish (of at least 0.35 kUA) at screening. Exclusion Criteria: * Serum codfish-specific IgE antibody level \> 100 kUA/L * History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) * Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) * FEV1 \<85% at rest and FEV1/FVC ≤ 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines) * Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis * Use of beta-blockers, and ACE inhibitors * Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis * Reacting to the placebo component during the study entry DBPCFC * Have received other food immunotherapy treatment in the preceding 12 months * Currently taking immunomodulatory therapy (including allergen immunotherapy) * Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant * History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE) * Subjects who in the opinion of the Site Investigator are unable to follow the protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
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