Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|2 Years - 10 Years
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Chinese University of Hong Kong
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Fish Allergy, Food Allergy in Children
|View Trial Website
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.
- - 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.
- - 59 is the Elimination Phase where participants continue on a fish-elimination diet post-treatment.
Active Comparator: Fish oral immunotherapy
Fish oral immunotherapy to be taken daily for 12 months.
Placebo Comparator: Placebo
Placebo oral immunotherapy to be taken daily for 12 months.
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.