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New treatment option for Allergy;Food
Official title Randomized Controlled Trial for Wheat Oral Immunotherapy
ClinicalTrials.gov ID: NCT06069492
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- 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:
You likely can't join 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:
See the full eligibility criteria
- 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 blinded, compared with an inactive treatment 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
- 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 blinded compared with an inactive treatment 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;
- On Intravenous immunoglobulin, systemic immunosuppressive or biologic within 3 months
- Inability to follow the requirements and protocol for wheat oral immunotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
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, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. 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.