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Test‐guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST)

Test‐guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST)
Test‐guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST)

Background: parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. Objective: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible. 

Methods: children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185. 

Results: from 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4–6 weeks) – with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%–100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. 

Conclusions: it is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

atopic eczema/dermatitis, feasibility RCT, food allergy, paediatrics
0954-7894
452-462
Ridd, Matthew J.
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Webb, Douglas
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Roberts, Kirsty
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Santer, Miriam
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Chalmers, Joanne R.
94e08e98-5c93-405d-9278-97acfe4985a0
Gilbertson, Anna
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Marriage, Deb
a62f4ce9-7cd9-4d71-9648-c4eb946743c9
Blair, Peter S.
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Turner, Nicholas L.
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Garfield, Kirsty
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Coast, Joanna
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Selman, Lucy E.
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Clement, Clare
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Shaw, Alison R.G.
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Muller, Ingrid
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Waddell, Lisa
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Angier, Elizabeth
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Taylor, Jodi
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Kai, Joe
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Boyle, Robert J.
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Ridd, Matthew J.
de8b7ad0-5afa-4231-99f6-d6778744ddd4
Webb, Douglas
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Roberts, Kirsty
567bcf1c-c441-4e96-af39-c49ccab64e80
Santer, Miriam
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Chalmers, Joanne R.
94e08e98-5c93-405d-9278-97acfe4985a0
Gilbertson, Anna
36d80e4d-4d78-4983-8c24-5b69ebe8060e
Marriage, Deb
a62f4ce9-7cd9-4d71-9648-c4eb946743c9
Blair, Peter S.
3d5e258e-a342-4f3f-98a3-195267ee7456
Turner, Nicholas L.
d39cd8de-09c1-45a0-a97e-776dca9b0c2b
Garfield, Kirsty
883d787b-29d1-4b86-816e-cbfc182c9bb3
Coast, Joanna
062a356d-95a4-46f0-af55-6f1438e8cd4d
Selman, Lucy E.
02cbaf7a-b687-40c3-a57b-0eb68deacc88
Clement, Clare
d7ce5b3a-6b2b-478c-a506-982fedeb96d4
Shaw, Alison R.G.
f0558e16-be1b-41ed-8694-90169586ebb9
Muller, Ingrid
2569bf42-51bd-40da-bbfd-dd4dbbd62cad
Waddell, Lisa
872c4b79-0174-4dcc-af8d-65e83586bf00
Angier, Elizabeth
d98c8257-d8b2-4aa6-bb77-42ba29757c52
Taylor, Jodi
875cc40a-d428-4a7d-9ee0-710051549a88
Kai, Joe
4149b8ab-84df-46e1-8735-4599809387e9
Boyle, Robert J.
cce30158-f576-4cd3-a790-421decaccec5

Ridd, Matthew J., Webb, Douglas, Roberts, Kirsty, Santer, Miriam, Chalmers, Joanne R., Gilbertson, Anna, Marriage, Deb, Blair, Peter S., Turner, Nicholas L., Garfield, Kirsty, Coast, Joanna, Selman, Lucy E., Clement, Clare, Shaw, Alison R.G., Muller, Ingrid, Waddell, Lisa, Angier, Elizabeth, Taylor, Jodi, Kai, Joe and Boyle, Robert J. (2021) Test‐guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST). Clinical & Experimental Allergy, 51 (3), 452-462. (doi:10.1111/cea.13816).

Record type: Article

Abstract

Background: parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. Objective: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible. 

Methods: children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185. 

Results: from 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4–6 weeks) – with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%–100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. 

Conclusions: it is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

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Accepted/In Press date: 27 December 2020
e-pub ahead of print date: 1 January 2021
Additional Information: Funding Information: The study was funded by National Institute for Health Research (NIHR) School for Primary Care Research (project 383). MJR was funded by an NIHR Post‐Doctoral Research Fellowship (PDF‐2014‐07‐ 013). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. Funding Information: This study was designed and is being delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research CTU support funding. The study was developed with support from UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. Trial steering and data monitoring committee members: Professor Carl Heneghan (chair), Dr David Gillespie (statistician), Dr Joanne Walsh (FP with specialist interest in allergy) and Kate Sykes (parent of child with eczema and food allergy). Publisher Copyright: © 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: atopic eczema/dermatitis, feasibility RCT, food allergy, paediatrics

Identifiers

Local EPrints ID: 446622
URI: http://eprints.soton.ac.uk/id/eprint/446622
ISSN: 0954-7894
PURE UUID: 564fba57-f197-4109-a0aa-a3562df40a45
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260
ORCID for Ingrid Muller: ORCID iD orcid.org/0000-0001-9341-6133

Catalogue record

Date deposited: 16 Feb 2021 17:32
Last modified: 10 Jan 2022 02:55

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Contributors

Author: Matthew J. Ridd
Author: Douglas Webb
Author: Kirsty Roberts
Author: Miriam Santer ORCID iD
Author: Joanne R. Chalmers
Author: Anna Gilbertson
Author: Deb Marriage
Author: Peter S. Blair
Author: Nicholas L. Turner
Author: Kirsty Garfield
Author: Joanna Coast
Author: Lucy E. Selman
Author: Clare Clement
Author: Alison R.G. Shaw
Author: Ingrid Muller ORCID iD
Author: Lisa Waddell
Author: Elizabeth Angier
Author: Jodi Taylor
Author: Joe Kai
Author: Robert J. Boyle

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