Fish Oral Immunotherapy in Hong Kong Children

NCT05590299 | Active Not Recruiting

• 1 other identifier: FOIT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fish Allergy; Food Allergy in Children

Keywords

Fish allergy; Codfish; Oral immunotherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve full desensitisation (passed T1 challenge) in OIT vs placebo.

  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.

  T2 - 8 weeks after final day of maintenance treatment

• The cumulative dose tolerated during the T1 challenge in OIT vs placebo.

  T1 - One Day after final day of maintenance treatment

• Skin prick test wheal size and fish-specific IgE to fish in OIT vs placebo.

  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.

  TEAEs will be collected until T2 - 8 weeks after final day of maintenance

Study Arms (2)

Fish oral immunotherapy

ACTIVE COMPARATOR

Fish oral immunotherapy to be taken daily for 12 months.

Other: Fish oral immunotherapy (codfish)

Placebo

PLACEBO COMPARATOR

Placebo oral immunotherapy to be taken daily for 12 months.

Other: Placebo oral immunotherapy

Interventions

Fish oral immunotherapy (codfish) OTHER

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

Fish oral immunotherapy

Placebo oral immunotherapy OTHER

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

Placebo

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Related Links

• Study information

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: January 6, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)