Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy

Launched by ATHENS GENERAL CHILDREN'S HOSPITAL "PAN. & AGLAIA KYRIAKOU" · Nov 21, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Specific Oral Tolerance Induction (SOTI) for children with a wheat allergy. The goal is to see if this method can safely help kids who have severe allergic reactions to wheat by gradually introducing them to small amounts of wheat over time. The study will involve 10 children aged 2 to 16 who have a confirmed allergy to wheat, as well as 5 other children who will be followed without treatment for comparison. Participants will start by eating a small amount of well-cooked wheat spaghetti daily, which will increase each week for about six months, followed by a maintenance period of daily wheat intake for another six months.

To be eligible for this study, children must have a history of allergic reactions to wheat and certain test results showing they have an IgE-mediated wheat allergy. Parents will need to provide written consent for their child to participate. Throughout the study, researchers will monitor the children's reactions to wheat using skin and blood tests, as well as additional food challenges to assess how their bodies respond to wheat over time. This trial is recruiting participants, and it's important to note that not all children with wheat allergies will meet the eligibility criteria, especially if they have other serious health issues or recent severe allergic reactions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 2-16 years
• • 2. Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and
• • 1. Positive SPT in wheat (\> 3 mm), and/or
• • 2. Wheat specific IgE f4 \> 0.35 kUa/L, and
• • 3. A positive Oral Food Challenge (OFC) to wheat, with the exception of patients who report a recent reaction (\< 3 months before study entry) after the consumption of wheat products
• • 3. Signed written consent form of the parents.
• Exclusion Criteria:
• • 1. Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
• • 2. Recent personal history (over the past 12 months) of severe anaphylactic reaction following wheat consumption, for which Intensive Care Unit (ICU) hospitalization was required, and/or
• • 3. Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
• • 4. Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
• • 5. Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
• • 6. Patients with cardiovascular disease or other significant systemic disease, and/or
• • 7. Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC).