The SynAD study aims to determine if daily treatment with an oral preparation containing healthy bacteria, given together with specific carbohydrates to help them thrive, is effective in reducing severity of atopic dermatitis (AD) in food allergic children aged between 6 months and 3 years.

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The aim of this study is to determine if daily treatment with an oral preparation containing a multi-strain synbiotic is effective in reducing severity of atopic dermatitis (AD) in food allergic children. A synbiotic is a combination of a probiotic and a prebiotic. Probiotics are living microorganisms that, when ingested in adequate amounts, can modulate gut microbiota. Prebiotics are indigestible oligosaccharides that give beneficial bacterial strains a selective advantage to thrive. When pre- and probiotics are given in the same preparation they have a synergistic effect, hence the name synbiotic. Studies using pre- and probiotics to prevent or treat AD have shown inconsistent results over the last 20 years. A recent meta-analysis of randomised controlled trials has concluded that synbiotics do have a role in the treatment of AD especially multi-strain synbiotics. (Chang et al, 2016) Infants and children 6 – 36 months who have attended allergy clinic at the Lady Cilento Children’s Hospital (LCCH) with moderate-to-severe atopic dermatitis and at least one food allergy will be eligible for the the SynAD study. Once recruited, families will attend 3 appointments - week 0, 6 and 12 at the Center for Children's Health Research (CCHR) where dietary, growth and skin assessment will occur. Questionnaires assessing food intake and quality of life will be collected at weeks 0 and 12. Stool samples will be collected for analysis for gut microbiota assessment at Weeks 0 and 12. There will be no change to standard care provided at LCCH. Patients will be randomised into either of two groups: an intervention and a placebo group. All study participants and investigators will be blinded to which intervention each patient is receiving until the end of the study. Families will be provided the intervention (either placebo or multi-strain synbiotic) with instructions on how to administer each day to their infant or child during appointments in week 0 and week 6. The aim of the study is to see a greater improvement in AD in the intervention compared to placebo group. Improvement in symptoms of AD will be measured by assessing severity of AD and the impact of AD on quality of life using two validated tools: *Scoring of Atopic Dermatitis (SCORAD) and *The Infant’s Dermatology Quality of Life Questionnaire (IDQOL) Chang, Y.S., M.K. Trivedi, and A. Jha, Synbiotics for prevention and treatment of atopic dermatitis - a meta-analysis of randomised clinical trials. JAMA Pediatr, 2016. 170(3): p. 236-242

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