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.
- paediatric dermatology
- paediatric dermatology
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Contributors AL is the principal investigator and has overall responsibility for all aspects of the PEBBLES trial. He initiated and designed the study with assistance from SD, JS, MT, MA, CFR and NC. SOB is the trial coordinator and responsible for day-to-day participant management and management of ethical approvals. SH and AS developed the participant recruitment strategy. MM and JH developed the plan for genetic analyses, while CJL developed the protocols and planned analyses for the biological samples (skin biome and breast milk assays). MT and KJA developed the protocol for food allergy outcomes, while JS and GV developed the skin and atopic dermatitis outcome assessments. MA and CFR developed the plans for assessment of respiratory outcomes in future follow-ups. AL and SOB wrote the first draft of this article. All authors were involved in critical revision of the article for important intellectual content. All the authors were involved in final approval of the article. Preparing study design, collection, management, analysis and interpretation of data; writing of the report and the decision to submit the report for publication is the responsibility of AL, the principal investigator.
Funding The PEBBLES study is investigator initiated; the University of Melbourne is the sponsor of the study. This work is supported by an NHMRC project grant (GNT1130010). Primus Pharmaceuticals, the manufacturer of EpiCeram has agreed to donate the intervention emollient to the study free of charge. Primus Pharmaceuticals will have no role in the collection, management, analysis and interpretation of data or decision to publish the study data.
Competing interests MT is a member of the Medical Advisory Board (Oceania) for Nestle Nutrition Institute, a member of the Medical Advisory Board (Australia New Zealand) for Danone Nutricia and a member of the Scientific Advisory Board for Immunology Allergy (Global) for Danone Nutricia; and has received lecture fees from Danone and Nestle Nutrition Institute; and has received travel fees from APAPARI. KJA has received speaker’s honoraria from Abbott, Danone, Nestle and Alphapharm. MA has received investigator-initiated grants from Pfizer and Boehringer-Ingelheim for unrelated research. He has also received from Sanofi assistance with conference attendance and an honorarium for an unrelated consultancy.
Ethics approval This study has been approved by the Royal Children’s Hospital (RCH) Human Research Ethics Committee (project 37090) and the Mercy Health Human Research Ethics Committee (project 2018–008) and was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12617001380381) on 28 September 2017 and with Clinical Trials.gov on 9 September 2018 as NCT03667651. The Universal Trial Number for this study is U1111-1201- 0431.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Obtained.
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