The PEBBLES study: A randomised controlled trial to prevent eczema, food allergy and sensitisation using a skin barrier improvement strategy
To determine if twice daily application of a ceramide dominant emollient can prevent the development of eczema and food allergy, when compared to standard skin management.
Allergic diseases (including eczema, food allergy, hay-fever and asthma) are a major cause of disease in Australia and around the world. It is suspected that at least a proportion of infants become sensitised to aspects of the environment through the skin due to poor skin barrier function in early life. In this phase 3 trial, we are testing if twice-daily application of EpiCeram™, a novel skin barrier repair emollient, to the skin of neonates for six months can improve skin barrier function (as measured by skin water loss). Mother/baby pairs will be recruited from the antenatal during late pregnancy and maternity wards postnatally. From birth to three weeks of age, children will be randomised to either the intervention group (daily EpiCeram™) or to the control group (standard skin care) for six months. An examination of skin barrier function will be performed at baseline and when the child is six weeks and 12 months of age an eczema examination will also occur. A skin prick test will be performed at 12 months (with any child exhibiting sensitisation given a food challenge), and a saliva sample will be collected at 12 months. Optional samples of lipid and biome samples via skin stripping and blood spots will be collected at baseline, six-weeks, six and 12 months, with breastmilk and oral microbiome collected at six-weeks.
To learn more about how to participate in PEBBLES, please visit our PEBBLES study website
Dr Melanie Matheson (Telstra Health)
Dr John Su (Royal Children's Hospital)
Associate Professor Mimi Tang (Site Investigator; Royal Children's Hospital)
Professor Shaun Brennecke (Site Investigator; Royal Women's Hospital)
Dr Arun Sasi (Site Investigator; Mercy Women's Hospital)
Professor Michael Abramson (Monash University)
Professor Katie Allen (Royal Children's Hospital)
Associate Professor Noel Cranswick (Royal Children's Hospital
Professor Colin Robertson (Royal Children's Hospital)
Professor George Varigos (Melbourne Hospital)
Dr Jenny Hui (University of Western Australia)
Ms Shaie O'Brien
Ms Simone Hamilton
Royal Children's Hospital
Murdoch Children's Research Institute
Royal Women's Hospital
Frances Perry Private Hospital
Mercy Women's Hospital
- National Health and Medical Research Council
Lowe AJ, et al. The PEBBLES pilot study: a phase I study of a ceramide-dominant triple lipid mixture for the prevention of eczema in neonates. BMC Dermatology. 2012, 12
Lowe AJ, et al. 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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