Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06069492
Other study ID # 6906974
Secondary ID 10210336
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date August 31, 2027

Study information

Verified date February 2024
Source Chinese University of Hong Kong
Contact Ting Fan Leung, MBChB, MD
Phone 85235052981
Email tfleung@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Intervention

Other:
Wheat-containing food
One daily serving of 38 grams wheat-containing pasta contains either 5000 mg wheat protein (standard-dose group) or 650 mg wheat protein and 4350 gluten-free flour (low-dose group)

Locations

Country Name City State
Hong Kong Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wheat-allergic patients who develop sustained unresponsiveness to wheat after oral immunotherapy The occurrence of sustained unresponsiveness to wheat is detected at 1 month after discontinuation of oral immunotherapy by double-blind, placebo-controlled wheat challenge 13 months
Secondary Wheat-allergic patients who develop desensitization to wheat after oral immunotherapy The occurrence of desensitization to wheat is detected at the end of 12-month oral immunotherapy by double-blind, placebo-controlled wheat challenge 12 months
Secondary Correlation among skin prick test (SPT), specific IgE level (sIgE) and basophil activation test (BAT) with crude wheat extract and wheat allergens and their diagnostic accuracy for wheat allergy Skin Prick Test, specific IgE and BAT with crude wheat extract and wheat allergens and their diagnostic accuracy for wheat allergy are correlated 3 years
Secondary Stepwise diagnostic algorithms of different biomarkers for wheat allergy Outcome provides a stepwise diagnostic algorithms of different biomarkers for wheat allergy 3 years
Secondary Changes in different allergy biomarkers after low-dose oral immunotherapy and standard-dose oral immunotherapy for wheat Changes in different allergy biomarkers that is skin prick test, specific IgE after low-dose and standard-dose OIT 18 months
Secondary Treatment compliance to wheat oral immunotherapy intervention Compliance to OIT intervention by diary record and the numbers of consuming products 12 months
Secondary Tolerability and safety between standard-dose and low-dose arms of wheat oral immunotherapy Assess the tolerability and safety between two oral immunotherapy arms by recording any adverse reactions or severe adverse reactions during the intervention period. 12 months
See also
  Status Clinical Trial Phase
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT02553486 - Internationally Adopted Children Quality of Life N/A
Completed NCT02918890 - Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia N/A
Completed NCT02903134 - Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
Active, not recruiting NCT01874847 - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin Phase 2/Phase 3
Enrolling by invitation NCT01971840 - Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. N/A
Enrolling by invitation NCT01971827 - Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance N/A
Completed NCT01738308 - The Effects of Healing Touch on Post Operative Pediatric Patients N/A
Completed NCT01693926 - Effect of Physical Activity an Stress in Children N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
Completed NCT01864811 - Effect of Baby-CIMT in Infants Younger Than 12 Months N/A
Completed NCT01323010 - Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes N/A
Completed NCT01277224 - Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren N/A
Active, not recruiting NCT00989547 - Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM) Phase 1
Completed NCT04051723 - Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children Phase 4
Completed NCT03236337 - Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit! N/A
Completed NCT03236363 - Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10! N/A
Not yet recruiting NCT03427697 - Effect of VR and Accommdation Relax on Controlling Myopia in Children N/A
Completed NCT05603507 - Inspiratory Muscle Training in Children With Chest Burn N/A
Not yet recruiting NCT06267339 - Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents Early Phase 1