Oral tolerance induction for children with wheat allergy

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

This study is testing if a new way of slowly introducing cooked wheat into the diets of children with wheat allergies can help them tolerate wheat better over a year.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 2 Years to 16 Years
• Sex: All
• Sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou" (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Athens)
• Trial ID: NCT03352193 on ClinicalTrials.gov

What this trial studies

This observational pilot study investigates the effectiveness and safety of Specific Oral Tolerance Induction (SOTI) in children aged 2-16 years with IgE-mediated wheat allergy. The study will include 10 patients who will undergo a 1-year home SOTI regimen involving daily consumption of well-cooked wheat spaghetti, with a gradual increase in dosage over 27 weeks. Additionally, a historical control group of 5 patients will be monitored without intervention for comparison. The study aims to assess immunological responses and desensitization through clinical evaluations and skin prick tests.

Who should consider this trial

Good fit: Ideal candidates are children aged 2-16 years with a confirmed IgE-mediated allergy to wheat.

Not a fit: Patients with a recent history of severe anaphylaxis to wheat or uncontrolled asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to a new treatment option that helps children with wheat allergies tolerate wheat, improving their quality of life.

How similar studies have performed: While similar approaches have been explored, this specific method of SOTI in children with wheat allergy is relatively novel.

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).

Where this trial is running

Athens

• Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou — Athens, Greece (Recruiting)

Study contacts

• Principal investigator: Nikolaos Kitsioulis, MD — National and Kapodistrian University of Athens
• Study coordinator: Nikolaos Kitsioulis, MD

Conditions Wheat Allergy