Condition category
Injury, Occupational Diseases, Poisoning
Date applied
31/07/2019
Date assigned
20/08/2019
Last edited
18/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
The impact of a food allergy is not just on the child and their immediate family but beyond that, due to the anxiety and stress it causes while trying to avoid contact of the child with the allergen. Children that have IgE, non-IgE or mixed symptoms to soybeans are recommended to avoid it in all its forms. Soya lecithin is extracted from soybean oil and it is used in the industry for the structure and the texture of many processed foods, but not more than 1% of soya lecithin is used in these foods. The limited studies that were published show that soya lecithin does not cause reactions in the IgE allergic child, but it has never been reviewed in the non-IgE soya allergic children. The aim of this study is to investigate allergenicity in non-IgE soya allergic children, because the elimination of soya lecithin from the diet of multiple allergic children limits their food choices significantly.

Who can participate?
Children between 8 months and 5 years of age with non-IgE soya allergy

What does the study involve?
Participants are randomly allocated to eat either a soya lecithin or non-soya lecithin containing biscuit daily for 1 week. This is followed by 1-week break before switching to the other biscuit for 1 week. The amount of soya lecithin in the biscuits is relative to the quantity found in processed foods sold in stores. The challenge foods are produced by DuPont Nutrition & Health (Solae, LLC), St. Louis, MO), USA. Both soya lecithin and placebo challenge foods are packaged in separate sealed coded envelopes (daily dosage within each container) and coded according to the random allocation. Symptoms are recorded before starting the study and at the end of each week. Questionnaires are filled out by parents at the start of the study and at the beginning of each week, and parents immediately report any complications caused during the 3 weeks. The gastroenterologist, dietitian and researcher on the case deal with problems if they occur. If parents report a reaction after week 1, the researcher is contacted and the researcher can extend the break if the reaction is deemed to be severe.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Great Ormond Street Hospital for Sick Children NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2014 to February 2015

Who is funding the study?
DuPont Nutrition & Health (USA)

Who is the main contact?
Yara Gholmie
yg2517@tc.columbia.edu

Trial website

Contact information

Type

Public

Primary contact

Ms Yara Gholmie

ORCID ID

http://orcid.org/0000-0002-3789-8534

Contact details

105 W 29th St
unit 27J
New York
10001
United States of America
+1 (0)6502696580
yg2517@tc.columbia.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nr.14/LO/0746

Study information

Scientific title

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

Acronym

Study hypothesis

Soya lecithin is present in a wide variety of foods regularly consumed by children, as an emulsifier or stabilizer. Children with non-IgE mediated allergies who commonly have to avoid milk and soya will have a significantly restrictive diet with reduced alternative foods, if soya lecithin also has to be eliminated. The objective is to establish if children with non-IgE mediated gastrointestinal soya allergy react to soya lecithin in food products.

Ethics approval

Approved 15/05/2014, NHS Health Research Authority- London, Bromley (Skipton House, 80 London Road, London,
SE1 6LH, UK; Tel: +44 (0)207 104 8019; +44 (0)207 104 8209; Email: nrescommittee.london-bromley@nhs.net), REC ref: 14/LO/0746

Study design

Double-blind randomised cross over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Non-IgE mediated soya allergy in children

Intervention

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 randomly assigned to either placebo or challenge dose of soya lecithin (1.5 g per day) in a custom-made biscuit. This was followed by 1-week washout period and crossover to another 1-week of challenge or placebo dose. Symptoms were recorded prior to commencing the study and at the end of each week’s challenge.

A previously published Likert scale symptom questionnaire in electronic format (www.surveymonkey.com) was used to monitor the symptoms during the study. This questionnaire was completed four times during the study. The first questionnaire was completed at baseline prior to commencing the study and a further three times by the parents during the food challenge: 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. 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 from 1 to 5 indicating what the child was feeling compared to the prior week after consuming the challenge biscuit on week 1 and 3.

Parents were required to contact the researcher if a reaction occurred during the study and questionnaires were reviewed by the researcher during the study to ensure accurate/correct recording of symptoms and to ensure that symptoms were not related to concomitant illness.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 outcome measures

Allergic reaction reported by parents at any time during the study

Overall trial start date

15/05/2014

Overall trial end date

13/03/2015

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Total final enrolment

22

Participant 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

Recruitment start date

01/09/2014

Recruitment end date

20/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital
Great Ormond Street Holborn
London
WC1N 3JH
United States of America

Sponsor information

Organisation

Great Ormond Street Hospital

Sponsor details

Great Ormond St
Holborn
London
WC1N 3JH
United Kingdom
+44 (0)20 7405 9200
gastro@gosh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

DuPont Nutrition & Health (Solae, LLC), St. Louis, MO), USA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study is currently under review with the Journal of Human Nutrition and Dietetics.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rosan Meyer (r.meyer@imperial.ac.uk).

Intention to publish date

01/09/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31603281 (added 18/03/2020)

Publication citations

Additional files

Editorial Notes

18/03/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 06/08/2019: Trial's existence confirmed by ethics committee.