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New treatment option for Food Allergy in Children
Official title Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
ClinicalTrials.gov ID: NCT06467994
What this study is testing
- What it's testing
- As the global prevalence of food allergy steadily increases, tree nut (TN) becomes one of the main triggers of food-allergic reactions and food anaphylaxis. Since there is no effective cure, TN-allergic patients and their families must continue to live with this chronic, disabling condition while avoiding allergens and responding to allergic reactions with emergency treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Aged between 2 year and 17 years of age;
- Either sex, and of any race and ethnicity;
- \>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext);
- Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashew nut and a positive SPT (\>=3mm than control) or sIgE to cashew...
- Subject's parent and/ or guardian must be able to understand and provide informed consent.
You likely can't join if
- History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than...
- Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or...
- Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
- Reacting to the placebo component during the study entry DBPCFC
- 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
See the full eligibility criteria
- Aged between 2 year and 17 years of age;
- Either sex, and of any race and ethnicity;
- \>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext);
- Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashew nut and a positive SPT (\>=3mm than control) or sIgE to cashew nut (of at least 0.35 kUA) at screening.
- Subject's parent and/ or guardian must be able to understand and provide informed consent.
- 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...
- 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...
- Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
- Reacting to the placebo component during the study entry DBPCFC
- 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, ACE inhibitors or calcium channel blockers
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or...
- Have received other food immunotherapy treatment in the preceding 6 months
- Currently taking immunomodulatory therapy (including allergen immunotherapy)
- Therapy with anti-IgE or other biologics within 1 year of enrolment
- 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)
- people who in the opinion of the Site Investigator are unable to follow the protocol NOTE: participants with other food allergies are NOT excluded from participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.