Skip to content

Soya lecithin and non-IgE soya allergy

Tolerance of soya lecithin in children with non-IgE mediated soya allergy: a randomized double-blind cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13583482
Enrollment
20
Registered
2019-08-20
Start date
2014-09-01
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-IgE mediated soya allergy in children Injury, Occupational Diseases, Poisoning

Interventions

A double-blind cross over study was performed in soya allergic children aged between 8 months-5 years. Eligible children had their soya allergy status confirmed with a home challenge. Children were ra
prior to commencing ‘week -2’ of the challenge
and at completion of the study. The parents received instructions on how to monitor their child’s symptoms during the study at the first assessment visit. Symptoms in the questionnaire were ranked fro

Sponsors

Great Ormond Street Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
Allergic reaction reported by parents at any time during the study

Countries

United Kingdom

Contacts

Public ContactYara Gholmie
yg2517@tc.columbia.edu+1 (0)6502696580

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026