Non-IgE mediated soya allergy in children Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children between 8 months and 5 years of age 2. Confirmed (through protocolised home re-introduction) non-IgE mediated gastrointestinal soya allergy 3. Wheat and corn syrup tolerant, as the challenge food contained both these ingredients 4. Stable in symptoms following the elimination diet and well managed from a dietary and medical perspective (no medication changes during the study)
Exclusion criteria
Exclusion criteria: 1. Patients who had commenced a new medication within 2 weeks of starting the study 2. Soya induced Food Protein Induced Enterocolitis Syndrome 3. As endoscopies are not routinely performed, this study did not distinguish between children that had eosinophilic oesophagitis, food protein-induced enteropathy and other non-IgE medidated food allergic conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Allergy symptoms measured using a previously published Likert scale symptom questionnaire in electronic format at baseline prior to commencing the study, after completion of “week 1” (prior to commencing the washout period), prior to commencing “week 2” of the challenge; and at completion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergic reaction reported by parents at any time during the study | — |
Countries
United Kingdom