Precision Diagnosis and Tolerance Induction in Children With Immediate-type Wheat Allergy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

IgE-mediated wheat allergy is a growing allergy problem in children, and affected children can predict with immediate-type allergic reactions to the extent of anaphylactic shock. Current diagnostic methods based on crude wheat extract are inaccurate and unreliable. Besides, these children are managed by a passive wait-and-see approach that reflect the natural history of wheat allergy. Nonetheless, a significant proportion of wheat-allergic children have persistent disease until school-age and adolescence. There is an unmet need for designing effective and safe immunotherapeutic strategy for wheat allergy. This study aims to investigate performance of allergy tests based on crude wheat and wheat allergens as measured using both quantitative and functional IgE-based assays for diagnosing IgE-mediated wheat allergy; and to compare efficacy and safety of different dosages of wheat oral immunotherapy (OIT) for treating these paediatric patients. For the initial part, this study will recruit children with immediate-onset adverse reactions after wheat ingestion for different allergy tests, with their wheat allergy ascertained by the gold-standard double-blind, placebo-controlled food challenge. The investigators will then recruit the wheat-allergic children into a randomized, double-blind, parallel-group clinical trial with low-dose and standard-dose wheat OIT for 12 months. The main outcomes include the diagnostic performance of different conventional and novel allergy tests for challenge-confirmed wheat allergy and the rates of desensitization and sustained unresponsiveness achieved by the two dosing regimens of wheat OIT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ First stage to diagnose immediate-type wheat allergy:

• 1-17 years old

• History of adverse reactions within four hours after foods containing wheat or gluten

• IgE sensitization to wheat by positive SPT or serum sIgE level

• Parent give informed written consent to participate

⁃ Second stage to commence oral immunotherapy of wheat for 12 months:

• Failed wheat double-blind, placebo-controlled food challenge (DBPCFC) under stage I

• 3-17 years old

• Body weight more than 8 kg

• IgE sensitization to wheat by positive SPT or serum sIgE level

• Parent give informed written consent to participate

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Ting Fan Leung, MBChB, MD
tfleung@cuhk.edu.hk
85235052981
Backup
Nam Sze Cheng, BN, MN, DN
nancycheng@cuhk.edu.hk
85290743896
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 72
Treatments
Active_comparator: Standard-dose group
Consumes one serving containing 38 grams wheat pasta daily for 6 days every week
Active_comparator: Low-dose group
Consumes one serving containing 5 grams wheat pasta and 33 grams gluten-free pasta daily for 6 days every week
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov