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

NCT03352193 | Recruiting

• 1 other identifier: Wheat SOTI
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Wheat Allergy

Outcome Measures

Primary Outcomes (1)

• Wheat allergic children achieving desensitization after 1 year of wheat home SOTI.

  The rate of wheat allergic children achieving desensitization after 1 year of wheat home SOTI.

  1 year

Secondary Outcomes (3)

• Variability of Skin Prick Tests (SPTs) pre and post 1-year SOTI intervention

  1 year

• Total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention

  1 year

• Wheat basophil activation test (BAT) pre and post 1-year SOTI intervention

  1 year

Study Arms (2)

SOTI group

Wheat spaghetti

Dietary Supplement: Wheat spaghetti

Historical control group

No intervention

Interventions

Wheat spaghetti DIETARY_SUPPLEMENT

Wheat oral immunotherapy

SOTI group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Wheat allergic patients visiting the Allergy Department of a tertiary University Children's Hospital

You may qualify if:

• 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.

You may not qualify if:

• Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
• 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
• Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
• Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
• Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
• Patients with cardiovascular disease or other significant systemic disease, and/or
• Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC).

Sponsors & Collaborators

• Athens General Children's Hospital "Pan. & Aglaia Kyriakou": lead

Study Sites (1)

Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou

Athens, 11527, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nikolaos Kitsioulis, MD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Nikolaos Papadopoulos, MD, PhD

  National and Kapodistrian University of Athens

  STUDY CHAIR

Central Study Contacts

Nikolaos Kitsioulis, MD

CONTACT

00302132009160; drnok21@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: January 8, 2018
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

GR (1)