The PEBBLES study: A randomised controlled trial to prevent eczema, food allergy and sensitisation using a skin barrier improvement strategy

Researcher

Project Details

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.

Project summary

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 six 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 collected from the six-week visit onward.

To learn more about how to participate in PEBBLES, please visit our PEBBLES study website

Researchers

Dr Adrian Lowe

Professor Shyamali Dharmage

Associate Professor Lyle Gurrin

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)

Dr Caroline Lodge

Ms Shaie O'Brien

Ms Simone Hamilton

Ms Adrienne White (Royal Women's Hospital)

Collaborators

Royal Children's Hospital

Murdoch Children's Research Institute

Royal Women's Hospital

Frances Perry Private Hospital

Mercy Women's Hospital

Funding

    National Health and Medical Research Council

Research Publications

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. A randomized trial of a barrier lipid replacement strategy for the prevention of atopic dermatitis and allergic sensitization: the PEBBLES pilot study. BJ. 2017, Vol 178/1

Research Group

Allergy and Lung Health



Faculty Research Themes

Infection and Immunology

School Research Themes

Screening and early detection of disease



Key Contact

For further information about this research, please contact the research group leader.

Department / Centre

Centre for Epidemiology and Biostatistics

Unit / Centre

Allergy and Lung Health


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