BridgeMD
Tests treatment safety and results for Food Allergy
Official title Efficacy of Cashew Nut Protein Immunotherapy
ClinicalTrials.gov ID: NCT06328504
What this study is testing
What is Cashew immunotherapy?
Cashew immunotherapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for food allergy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 17
You may be able to join if
- age between 4 and 17 years,
- IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than...
- allergic reaction to cashew protein during oral food challenge (OFC),
- Signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
- Patient's and caregivers' cooperation with the researcher.
You likely can't join if
- no confirmed allergy to cashew,
- negative provocation test with cashew,
- severe asthma,
- mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) \<80% (less than 5 perc), FEV1/FVC (forced expiratory volume at...
- oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
- eosinophilic gastroenteritis,
See the full eligibility criteria
- age between 4 and 17 years,
- IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo...
- allergic reaction to cashew protein during oral food challenge (OFC),
- Signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
- Patient's and caregivers' cooperation with the researcher.
- no confirmed allergy to cashew,
- negative provocation test with cashew,
- severe asthma,
- mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) \<80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) \<75% (less than 5 perc)...
- oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
- eosinophilic gastroenteritis,
- chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- taking medications:
- oral, daily steroid therapy \>1 month in the past 12 months,
- a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,
- one-time oral steroid therapy (min. 7 days) in the last 3 months,
- biological treatment,
- need to take antihistamines continuously,
- therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,
- pregnancy,
- lack of consent to participate in the study,
- lack of patient cooperation.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
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, 4 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.