PEBBLES

*This page is for general information only. If you are interested in participating in this study, please visit the PEBBLES study website for more information.*

Study short name: PEBBLES

Study full name: THE PEBBLES STUDY: A randomised controlled trial to prevent eczema, food allergy and sensitisation using a skin barrier improvement strategy

Principle Investigator: Adrian Lowe

Administering Institute: University of Melbourne

Major funding source: National Health and Medical Research Council (NHMRC)

Study focus: Prevention

Study design: Intervention

Main study aim: We are aiming to find out if infant skin management with a particular cream, called EpiCeram™, might help reduce the chances that a child will develop allergies.

Additional study information: Eczema is often the first sign that an infant has allergies, and infants with eczema often go on to develop food allergies and other allergic diseases and asthma. It is likely that eczema allows substances from the environment (allergens) to be exposed to the immune system through the damaged skin, resulting in allergies (sensitisation). EpiCeram™ is a cream that has been designed to help build up the skin's ability to be a barrier against the environment. This treatment contains the major components of human skin at physiological concentration. Our study intends to find out if building and maintaining infants' skin barrier function can prevent eczema and food allergies and eventually asthma.

Study population: 0-3 week old infants with family history allergy.  Specifically, either one or both of the baby's biological parents and/or siblings must suffer from any of the following conditions; asthma, eczema/atopic dermatitis, hayfever/allergic rhinitis or food allergy.

Study status: Recruitment ongoing, through September 2020.

Study website: www.mspgh.unimelb.edu.au/visit/pebblesstudy

Australia New Zealand Clinical Trials Registry: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12617001380381p

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03667651

Study contact: [email protected]

Last modified: March 6th 2020 | Date created: April 9th 2019