Randomized Controlled Trial for Wheat Oral Immunotherapy

NCT06069492 | Recruiting

• 2 other identifiers: 690697410210336
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy;Food; Wheat Allergy; Children

Keywords

food allergy; wheat; oral immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Wheat-allergic patients who develop desensitization to wheat after oral immunotherapy

  12 months

• 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

  3 years

• Stepwise diagnostic algorithms of different biomarkers for wheat allergy

  3 years

• Changes in different allergy biomarkers after low-dose oral immunotherapy and standard-dose oral immunotherapy for wheat

  18 months

• Treatment compliance to wheat oral immunotherapy intervention

  12 months

Study Arms (2)

Standard-dose group

ACTIVE COMPARATOR

Consumes one serving containing 38 grams wheat pasta daily for 6 days every week

Other: Wheat-containing food

Low-dose group

ACTIVE COMPARATOR

Consumes one serving containing 5 grams wheat pasta and 33 grams gluten-free pasta daily for 6 days every week

Other: Wheat-containing food

Interventions

Wheat-containing food OTHER

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)

Low-dose group; Standard-dose group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• First stage to diagnose immediate-type wheat allergy:
• 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
• 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

You may not qualify if:

• First stage for diagnosis of immediate-type wheat allergy:
• Eczema flare or severe allergic reactions within 4 weeks
• Intake of antihistamines within 1 week
• Systemic corticosteroid treatment within 4 weeks
• Intravenous immunoglobulin, systemic immunosuppressive or biologic within 3 months
• Inability to follow the requirements and expected procedure of DBPCFC
• Second stage of wheat oral immunotherapy for 12 months:
• History of severe anaphylaxis to wheat
• Severe anaphylaxis during double-blind placebo-controlled wheat challenge from stage 1
• Active medical conditions
• Use of beta-blockers or angiotensin-converting enzyme inhibitors
• Have received other food oral immunotherapy treatment within 12 months
• Eczema flare or severe allergic reactions within 4 weeks;
• Intake of antihistamines within 1 week
• Systemic corticosteroid treatment within 4 weeks;

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity; Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ting Fan Leung, MBChB, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Fan Leung, MBChB, MD

CONTACT

85235052981; tfleung@cuhk.edu.hk

Nam Sze Cheng, BN, MN, DN

CONTACT

85290743896; nancycheng@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff performing laboratory assays
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 5, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon completion of this 36-month study, and available for share for 5 years
• Access Criteria: Need to contact the principal investigator to obtain agreement to share such IPD

Locations

HK (1)