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