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ACTIVE NOT RECRUITING

NCT05590299

Fish Oral Immunotherapy in Hong Kong Children

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

2 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-06

Completion Date

2025-12

Last Updated

2024-06-14

Healthy Volunteers

Conditions

Fish Allergy Food Allergy in Children

Interventions

OTHER

Fish oral immunotherapy (codfish)

Codfish in mixture of potato prepared under food manufacturing regulations provided in varying doses

OTHER

Placebo oral immunotherapy

Placebo in potato mixture prepared under food manufacturing regulations provided in varying doses

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

Locations (1)

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong