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PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy.

ABSTRACT: INTRODUCTION:The skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if application of a ceramide-dominant emollient two times per day reduces the risk of AD and food allergy, we have commenced a multicentre phase III, outcome assessor blinded, randomised controlled trial of this emollient applied from birth to 6?months. METHODS AND ANALYSIS:Infants (n=760) with a family history of allergic disease will be recruited from maternity hospitals in Melbourne. The primary outcomes are as follows: the presence of AD, assessed using the UK Working Party criteria, and food allergy using food challenge, in the first 12 months of life as assessed by a blinded study outcome assessor. Secondary outcomes are as follows: food sensitisation (skin prick test), skin barrier function, AD severity, the presence of new onset AD after treatment cessation (between 6 and 12 months) and the presence of parent reported AD/eczema. Recruitment commenced in March 2018. ETHICS AND DISSEMINATION:The PEBBLES Study is approved by the Human Research Ethics Committees of the Royal Children's Hospital (RCH) (#37090A) and the Mercy Hospital for Women (2018-008). Parents or guardians will provide written informed consent. Outcomes will be disseminated through peer-reviewed publications and presented at scientific conferences. TRIAL REGISTRATION NUMBERS:ACTRN12617001380381 and NCT03667651.

SUBMITTER: Lowe A

PROVIDER: S-EPMC6430027 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy.

Lowe Adrian A Su John J Tang Mimi M Lodge Caroline J CJ Matheson Melanie M Allen Katrina J KJ Varigos George G Sasi Arun A Cranswick Noel N Hamilton Simone S Robertson Colin F CF Hui Jennie J Abramson Michael M O'Brien Shaie S Dharmage Shyamali S

BMJ open 20190313 3

<h4>Introduction</h4>The skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if ...[more]

PMID: 30867201

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Project description:PurposeHouse dust mite (HDM) is the predominant cause of allergic rhinitis (AR) in Hong Kong but remains under-diagnosed and -treated. The association between patient-reported outcome measures (PROMs) and nasoendoscopy findings for AR have also not been investigated. This study investigated the demographics, sensitisation patterns, quality of life, use of sublingual immunotherapy and the association of PROMs and nasoendoscopy findings in AR patients through the first allergist-otorhinolaryngologists AR joint (ARJ) clinic in Hong Kong.MethodsThis single-centred, retrospective observational study was conducted between January 2021 and December 2021. Clinical data from AR patients attending the ARJ clinic were analysed to identify the prevalence of HDM allergens, change in PROMs and the association of PROMs with nasoendoscopy scores.ResultsThe three most common sensitising HDM allergens were Dermatophagoides pterynosinus (94.4%), Dermatophagoides farinae (88.9%) and Euroglyphus maynei (88.9%). At the 13- to 32-week follow-up (median 28 weeks), patients who attended the ARJ clinic had significant improvement in Total Nasal Symptom Score (TNSS; p = 0.038). The visual analogue scale (VAS) was associated with nasoendoscopy score (p = 0.018). Patients using SLIT (sublingual immunotherapy) showed overall improvements in PROMs.ConclusionThe ARJ clinic significantly improved AR symptoms. SLIT was effective and safe for patients who failed conventional treatments. VAS positively correlated with nasoendoscopy findings. Testing for Dermatophagoides pterynosinus as a single agent during skin testing was sufficient for the diagnosis of HDM AR and should be prioritized when resources are restricted. Further studies should be done to investigate the treatment outcome of AR patients and the effectiveness of SLIT in the Chinese population.Supplementary informationThe online version of this article (10.1007/s40629-022-00218-5) contains supplementary material, which is available to authorized users.

Dataset Information

PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy.

Publications

PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy.

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