NCT05590299

Fish Oral Immunotherapy in Hong Kong Children

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fish Allergy
• Food Allergy in Children

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-06
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-10-21
• Last updated: 2024-06-14

Locations

1 site across 1 country: Hong Kong