Clinical Trials

Fish Oral Immunotherapy in Hong Kong Children

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 10 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05590299
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chinese University of Hong Kong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Hong Kong
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fish Allergy, Food Allergy in Children
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Fish oral immunotherapy

Fish oral immunotherapy to be taken daily for 12 months.

Placebo Comparator: Placebo

Placebo oral immunotherapy to be taken daily for 12 months.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hong Kong, Hong Kong

Status

Address

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

Hong Kong, ,

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