Fish AllergyNCT05590299
Fish Oral Immunotherapy in Hong Kong Children
A study testing Fish oral immunotherapy (codfish) in people with Fish Allergy and Food Allergy in Children, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe, but we know that accidental exposure is common. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Fish Allergy, Food Allergy in Children
- What is being tested?
- Fish oral immunotherapy (codfish)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Randomised, Controlled Trial Evaluating the Effectiveness of Fish Oral Immunotherapy (FOIT) in Inducing Desensitisation or Remission in Children With Fish Allergy Compared With Placebo
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe, but we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed.
This study is a randomized controlled trial to evaluate the effectiveness of Fish Immunotherapy (FOIT), with codfish as the primary focus, in inducing tolerance in children with fish allergy compared with Placebo. Children will take increasing doses of codfish protein until a total of 12 months treatment is completed. Children will be tested for fish allergy at the start of the study, at the end of fish treatment T1 (12 months) and T2 (8 weeks) after treatment.
Read the detailed description
This is a two-armed, randomised (1:1), blinded, placebo-controlled, parallel-group, superiority trial.
The study consists of:
Screening visit occurs within three months before Day 1.
Day 1 Rush Induction Phase is the start of treatment where participants receive increasing doses of fish (or placebo) OIT every 20 minutes to reach a predefined dose of fish protein (or placebo).
Week 1 - 12 is the Buildup Phase where the daily dose of fish (or placebo) OIT is increased every 2 weeks* until a maintenance dose of fish protein (or placebo) is reached. This is expected to take 12 weeks.
Week 13 - 52 is the Maintenance Phase where participants take a daily dose of fish protein (or placebo) at home and continue until a total of 12 months of treatment is completed.
Week 53 - 59 is the Elimination Phase where participants continue on a fish-elimination diet post-treatment.
The primary outcome analysis will be conducted when all subjects have either completed the T2 DBPCFC or terminated the study prior to their T2 visit. Analysis of safety and tolerability, and other secondary outcomes to the T2 timepoint will also be conducted at this time.
- Conditions
- Fish Allergy, Food Allergy in Children
- Being tested
- Fish oral immunotherapy (codfish), Placebo oral immunotherapy
- Keywords
- Fish allergy, Codfish, Oral immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oral immunotherapy (codfish)Other
Codfish in mixture of potato prepared under food manufacturing regulations provided in varying doses
Placebo oral immunotherapyOther
Placebo in potato mixture prepared under food manufacturing regulations provided in varying doses
| Study group | Role | What they receive |
|---|---|---|
| Fish oral immunotherapy | Active comparator | Fish oral immunotherapy to be taken daily for 12 months. Receives: Other: Fish oral immunotherapy (codfish) |
| Placebo | Placebo comparator | Placebo oral immunotherapy to be taken daily for 12 months. Receives: Other: Placebo oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve full desensitisation (passed T1 challenge) in OIT vs placebo.
Measured: T1 - One Day after final day of maintenance treatment
Secondary outcomes (4)
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in OIT vs placebo.
Measured: T2 - 8 weeks after final day of maintenance treatment
The cumulative dose tolerated during the T1 challenge in OIT vs placebo.
Measured: T1 - One Day after final day of maintenance treatment
Skin prick test wheal size and fish-specific IgE to fish in OIT vs placebo.
Measured: M1 - At 6 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in OIT vs placebo.
Measured: TEAEs will be collected until T2 - 8 weeks after final day of maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start6 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fish AllergyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Sze-Yin Leung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590299
- Sponsor's protocol ID
- FOIT
- Status last verified
- May 2026
- First submitted
- 19 Oct 2022
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung AS, Gu Y, Au AW, Leung RT, Tang VH, Fung KY, Li JM, Wai CY, Leung TF, Wong GW. Codfish Oral Immunotherapy in Children Aged 2-10: Randomized Placebo-Controlled Study. Allergy. 2026 May;81(5):1799-1812. doi: 10.1111/all.70268. Epub 2026 Feb 17.
PubMed 41704072
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Trial Evaluating the Effectiveness of Fish Oral Immunotherapy (FOIT) in Inducing Desensitisation or Remission in Children With Fish Allergy Compared With Placebo
- ClinicalTrials.gov ID
- NCT05590299
- Acronym / sponsor ID
- FOIT
- Conditions
- Fish Allergy, Food Allergy in Children
- Keywords
- Fish allergy, Codfish, Oral immunotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe, but we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed.
This study is a randomized controlled trial to evaluate the effectiveness of Fish Immunotherapy (FOIT), with codfish as the primary focus, in inducing tolerance in children with fish allergy compared with Placebo. Children will take increasing doses of codfish protein until a total of 12 months treatment is completed. Children will be tested for fish allergy at the start of the study, at the end of fish treatment T1 (12 months) and T2 (8 weeks) after treatment.
Detailed description
This is a two-armed, randomised (1:1), blinded, placebo-controlled, parallel-group, superiority trial.
The study consists of:
Screening visit occurs within three months before Day 1.
Day 1 Rush Induction Phase is the start of treatment where participants receive increasing doses of fish (or placebo) OIT every 20 minutes to reach a predefined dose of fish protein (or placebo).
Week 1 - 12 is the Buildup Phase where the daily dose of fish (or placebo) OIT is increased every 2 weeks* until a maintenance dose of fish protein (or placebo) is reached. This is expected to take 12 weeks.
Week 13 - 52 is the Maintenance Phase where participants take a daily dose of fish protein (or placebo) at home and continue until a total of 12 months of treatment is completed.
Week 53 - 59 is the Elimination Phase where participants continue on a fish-elimination diet post-treatment.
The primary outcome analysis will be conducted when all subjects have either completed the T2 DBPCFC or terminated the study prior to their T2 visit. Analysis of safety and tolerability, and other secondary outcomes to the T2 timepoint will also be conducted at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oral immunotherapy | Active comparator | Other: Fish oral immunotherapy (codfish)Fish oral immunotherapy to be taken daily for 12 months. |
| Placebo | Placebo comparator | Other: Placebo oral immunotherapyPlacebo oral immunotherapy to be taken daily for 12 months. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oral immunotherapy (codfish)Codfish in mixture of potato prepared under food manufacturing regulations provided in varying doses | Other | Fish oral immunotherapy |
| Placebo oral immunotherapyPlacebo in potato mixture prepared under food manufacturing regulations provided in varying doses | Other | Placebo |
Primary outcome
Proportion of participants who achieve full desensitisation (passed T1 challenge) in OIT vs placebo.
Time frame: T1 - One Day after final day of maintenance treatment
4 secondary outcomes
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in OIT vs placebo.
Time frame: T2 - 8 weeks after final day of maintenance treatment
The cumulative dose tolerated during the T1 challenge in OIT vs placebo.
Time frame: T1 - One Day after final day of maintenance treatment
Skin prick test wheal size and fish-specific IgE to fish in OIT vs placebo.
Time frame: M1 - At 6 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in OIT vs placebo.
Time frame: TEAEs will be collected until T2 - 8 weeks after final day of maintenance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 41704072Leung AS, Gu Y, Au AW, Leung RT, Tang VH, Fung KY, Li JM, Wai CY, Leung TF, Wong GW. Codfish Oral Immunotherapy in Children Aged 2-10: Randomized Placebo-Controlled Study. Allergy. 2026 May;81(5):1799-1812. doi: 10.1111/all.70268. Epub 2026 Feb 17.
- Study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oral immunotherapy (codfish) in people with Fish Allergy and Food Allergy in Children, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve full desensitisation (passed T1 challenge) in OIT vs placebo. (time frame: T1 - One Day after final day of maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.