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Fish Oral Immunotherapy in Hong Kong Children

Primary Purpose

Fish Allergy, Food Allergy in Children

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Fish oral immunotherapy (codfish)

Placebo oral immunotherapy

About this trial

This is an interventional treatment trial for Fish Allergy focused on measuring Fish allergy, Codfish, Oral immunotherapy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged between 3 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fish oral immunotherapy

Placebo

Arm Description

Fish oral immunotherapy to be taken daily for 12 months.

Placebo oral immunotherapy to be taken daily for 12 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in OIT vs placebo.

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

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

Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in OIT vs placebo.

Full Information

NCT ID

NCT05590299

First Posted

October 19, 2022

Last Updated

February 6, 2023

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT05590299

Brief Title

Fish Oral Immunotherapy in Hong Kong Children

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fish Allergy, Food Allergy in Children

Keywords

Fish allergy, Codfish, Oral immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fish oral immunotherapy

Arm Type

Active Comparator

Arm Description

Fish oral immunotherapy to be taken daily for 12 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo oral immunotherapy to be taken daily for 12 months.

Intervention Type

Other

Intervention Name(s)

Fish oral immunotherapy (codfish)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo oral immunotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

T1 - One Day after final day of maintenance treatment

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leung Agnes

Phone

+85335052859

agnes.syl@cuhk.edu.hk

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Fan Leung

Phone

+85335052981

tfleung@cuhk.edu.hk

Facility Information:

Facility Name

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

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnes Leung

Phone

+85235052859

agnes.syl@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.allergycuhk.org/foit

Description

Study information

Learn more about this trial

Fish Oral Immunotherapy in Hong Kong Children

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