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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Observational
SUMMARY

This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children with IgE-mediated wheat allergy. The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention. Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase). Subsequently, wheat protein maintenance dose will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat. Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC. Regarding historical control group the same testing will be performed at baseline and at re-evaluation (post 12 months).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:

• Age 2-16 years

• Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and

‣ Positive SPT in wheat (\> 3 mm), and/or

⁃ Wheat specific IgE f4 \> 0.35 kUa/L, and

⁃ 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

• Signed written consent form of the parents.

Locations
Other Locations
Greece
Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou
RECRUITING
Athens
Contact Information
Primary
Nikolaos Kitsioulis, MD
drnok21@gmail.com
00302132009160
Time Frame
Start Date: 2018-01-08
Estimated Completion Date: 2025-10-10
Participants
Target number of participants: 15
Treatments
SOTI group
Wheat spaghetti
Historical control group
No intervention
Related Therapeutic Areas
Sponsors
Leads: Athens General Children's Hospital Pan. & Aglaia Kyriakou

This content was sourced from clinicaltrials.gov