Skincare and synbiotics for the prevention of atopic dermatitis or food allergy in newborn infants: a 2x2 factorial randomized non-treatment controlled trial

Author(s):  
Eishika  Dissanayake
2019 ◽  
Vol 180 (3) ◽  
pp. 202-211 ◽  
Author(s):  
Eishika Dissanayake ◽  
Yumi Tani ◽  
Kazue Nagai ◽  
Masumi Sahara ◽  
Chisako Mitsuishi ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024594 ◽  
Author(s):  
Adrian Lowe ◽  
John Su ◽  
Mimi Tang ◽  
Caroline J Lodge ◽  
Melanie Matheson ◽  
...  

IntroductionThe 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 analysisInfants (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 disseminationThe 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 numbersACTRN12617001380381 andNCT03667651.


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