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. 2019 Mar 13;9(3):e024594.
doi: 10.1136/bmjopen-2018-024594.

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

Adrian Lowe  1   2 , John Su  2   3   4   5 , Mimi Tang  2   3   5 , Caroline J Lodge  1   2 , Melanie Matheson  1 , Katrina J Allen  2   3 , George Varigos  6 , Arun Sasi  7 , Noel Cranswick  2   5 , Simone Hamilton  1   2 , Colin F Robertson  2   5 , Jennie Hui  8 , Michael Abramson  9 , Shaie O'Brien  1   2 , Shyamali Dharmage  1   2
Affiliations

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

Adrian Lowe et al. BMJ Open. .

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.

Keywords: allergy; asthma; eczema; paediatric dermatology.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Study flow diagram.
See this image and copyright information in PMC

References

    1. Ierodiakonou D, Garcia-Larsen V, Logan A, et al. . Timing of allergenic food introduction to the infant diet and risk of allergic or autoimmune disease: a systematic review and meta-analysis. JAMA 2016;316:1181–92. 10.1001/jama.2016.12623 - DOI - PubMed
    1. Martin PE, Eckert JK, Koplin JJ, et al. . Which infants with eczema are at risk of food allergy? Results from a population-based cohort. Clin Exp Allergy 2015;45:255–64. 10.1111/cea.12406 - DOI - PubMed
    1. Lowe AJ, Carlin JB, Bennett CM, et al. . Do boys do the atopic march while girls dawdle? J Allergy Clin Immunol 2008;121:1190–5. 10.1016/j.jaci.2008.01.034 - DOI - PubMed
    1. Lowe AJ, Abramson MJ, Hosking CS, et al. . The temporal sequence of allergic sensitization and onset of infantile eczema. Clin Exp Allergy 2007;37:536–42. 10.1111/j.1365-2222.2007.02691.x - DOI - PubMed
    1. Hopper JL, Bui QM, Erbas B, et al. . Does eczema in infancy cause hay fever, asthma, or both in childhood? Insights from a novel regression model of sibling data. J Allergy Clin Immunol 2012;130:1117–22. 10.1016/j.jaci.2012.08.003 - DOI - PubMed

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