Food Allergy in Children Clinical Trial
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
Verified date | June 2024 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants who achieve full desensitisation (passed T1 challenge) in OIT vs placebo. | T1 - One Day after final day of maintenance treatment | ||
Secondary | 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 | ||
Secondary | The cumulative dose tolerated during the T1 challenge in OIT vs placebo. | T1 - One Day after final day of maintenance treatment | ||
Secondary | 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 | ||
Secondary | 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 |
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 |