Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467994
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-13
Brief Title:
Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Randomised Controlled Trial Evaluating the Effectiveness of Boiled Cashew OraL immunoTherapy BOLT in Inducing Desensitisation or Remission in Children With Cashew Nut Allergy Compared With Placebo
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 An emerging experimental treatment for food allergy is oral immunotherapy OIT Tree nut OIT appears promising in preliminary studies but there are concerns about the high risk of adverse reactions to TNs used in the treatment The rate of remission with TN OIT is also lacking Identification of OIT regimes with increased efficacy and safety is urgently needed The investigators revealed that boiled cashews had lower allergenic potential but retained mast cell reactivity The aim of this proposed study is to investigate the efficacy and safety of a novel treatment strategy for TN-allergic individuals whereby the investigators hypothesized that consuming increasing quantities of boiled cashews can induce desensitization remission to roasted tree nuts in children with cashew allergies
Detailed Description:
This will be a two-arm parallel-design double-blind randomized controlled trial Participants aged 3-17 years of age with double blind placebo-controlled food challenge-confirmed cashew allergy will be randomised into either the active or placebo arm The active and placebo participants will consume daily dose of cashew and placebo respectively for 52 weeks Participants will undergo an initial escalation and build-up phase until they reach a maintenance dose of cashew or placebo Participants will return at 6 months for a safety and compliance check and at 12 months T1 and 14 months T2 for endpoint oral food challenges Level of cross-desensitization to pistachio will be examined at T1 Immunological changes including sIgE and IgG4 will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None