Fish Oral Immunotherapy in Hong Kong Children

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05590299
Study type	Interventional
Source	Chinese University of Hong Kong
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 6, 2023
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05839405` - Food Allergy in the Brain
Completed	`NCT04378335` - Assessment of Orality Disorders in Children With Food Allergies	N/A
Recruiting	`NCT03776474` - Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children
Completed	`NCT05794568` - Evaluate the Efficacy of the OITcontrol Application.	N/A
Active, not recruiting	`NCT05165329` - A Randomized, Controlled Trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Tolerance in Hong Kong Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo	N/A
Completed	`NCT05093114` - Friends, Family & Food: Food Allergy App for Youth ( F3A-App )
Recruiting	`NCT05406141` - Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy	N/A
Completed	`NCT05111938` - Friends, Family & Food: Food Allergy App for Youth - II	N/A
Recruiting	`NCT06034678` - Evaluation of The Food Allergy Mastery Program	N/A
Recruiting	`NCT06467994` - Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children	Phase 2
Not yet recruiting	`NCT04407104` - Allergy to Almond in Children
Enrolling by invitation	`NCT05287074` - The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children
Enrolling by invitation	`NCT04955132` - Impact of E-learning on Parental Confidence in Managing Food Allergy	N/A
Recruiting	`NCT03309488` - Basophil Activation Test to Diagnose Food Allergy
Recruiting	`NCT05707858` - The Naples Pediatric Food Allergy (NAPFA) Score
Suspended	`NCT04198753` - Skin Characteristics of Parents of Food Allergic Pediatric Patients
Recruiting	`NCT05309772` - The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy	N/A
Recruiting	`NCT04376242` - Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge	N/A
Completed	`NCT04770727` - CBT Group Intervention for Children With Food Allergy and Anxiety	N/A
Completed	`NCT04512924` - The Psychosocial Outcomes in Caregivers of Children With Food Allergy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.