Skin Care and Synbiotics for Prevention of Atopic Dermatitis or Food Allergy in Newborn Infants: A 2 × 2 Factorial, Randomized, Non-Treatment Controlled Trial

Dissanayake, Eishika; Tani, Yumi; Nagai, Kazue; Sahara, Masumi; Mitsuishi, Chisako; Togawa, Yaei; Suzuki, Yôichi; Nakano, Taiji; Yamaide, Fumiya; Ohno, Hiroshi; Shimojo, Naoki

doi:10.1159/000501636

Cited by 70 publications

(80 citation statements)

References 21 publications

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“…In infants at general risk, one trial examined synbiotics ( B bifidum OLB6378 plus fructo‐oligosaccharides) from birth to 6 months (food allergy prevalence at 1 year, RR: 1.03; CI: 0.63‐1.68, P > .05, low certainty) 63 …”

Section: Resultsmentioning

confidence: 99%

Preventing food allergy in infancy and childhood: Systematic review of randomised controlled trials

Silva¹,

Halken

Singh³

et al. 2020

Pediatric Allergy Immunology

148

140

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Background: This systematic review of ways to prevent immediate-onset/IgEmediated food allergy will inform guidelines by the European Academy of Allergy and Immunology (EAACI). Methods: The GRADE approach was used. Eleven databases were searched from 1946 to October 2019 for randomized controlled trials (and large prospective cohort studies in the case of breastfeeding). The studies included heterogeneous interventions, populations, and outcomes and so were summarized narratively. Results: Forty-six studies examined interventions to reduce the risk of food allergy in infancy (up to 1 year) or early childhood. The following interventions for pregnant or breastfeeding women and/or infants may have little to no effect on preventing food allergy, but the evidence is very uncertain: dietary avoidance of food allergens, vitamin supplements, fish oil, probiotics, prebiotics, synbiotics, and emollients. Breastfeeding, hydrolyzed formulas, and avoiding cow's milk formula may not reduce the risk of cow's milk protein allergy; however, temporary supplementation with cow's milk formula in the first week of life may increase the risk of cow's milk allergy. Introducing well-cooked egg, but not pasteurized raw egg, from 4 to 6 months probably reduces the risk of hen's egg allergy. Introducing regular peanut consumption into the diet of an infant at increased risk beginning from 4 to 11 months probably results in a large reduction in peanut allergy in countries with a high prevalence. These conclusions about introducing peanut are based on moderate certainty evidence, from single trials in high-income countries. Conclusions: Sixty percent of the included studies were published in the last 10 years, but much still remains to be understood about preventing food allergy. In particular, 2 | ME THODS The systematic review was conducted by a task force made up of allergy, gastroenterology, primary care and dietetic clinicians,

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Section: Resultsmentioning

confidence: 99%

Preventing food allergy in infancy and childhood: Systematic review of randomised controlled trials

Silva¹,

Halken

Singh³

et al. 2020

Pediatric Allergy Immunology

148

140

View full text Add to dashboard Cite

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“…Both studies showed no significant reduction in the incidence of AD, and in the BEEP study, there was an increased rate of infections and a trend toward increased food allergy in the intervention group 113,114 . Similarly, an RCT by Dissanayake et al compared the incidence of AD and FA in the first year of life in infants treated with synbiotics and an emollient (alone or in combination) and controls and found no statistical difference 163 . The negative findings in these studies were surprising given the pilot study findings, and the authors discussed various reasons as to why this might have occurred including low adherence rate with the intervention (especially PreventADALL), contamination of the control arm (BEEP), and the type of emollient used.…”

Section: The Role Of Emollients To Prevent the Development Of Food Allergymentioning

confidence: 99%

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Brough

Nadeau

Sindher

et al. 2020

Allergy

191

168

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There is increasing evidence regarding the importance of allergic sensitization through the skin. In this review, we provide an overview of the atopic march and immune mechanism underlying the sensitization and effector phase of food allergy. We present experimental models and human data that support the concept of epicutaneous sensitization and how this forms one half of the dual‐allergen exposure hypothesis. We discuss specific important elements in the skin (FLG and other skin barrier gene mutations, Langerhans cells, type 2 innate lymphoid cells, IL‐33, TSLP) that have important roles in the development of allergic responses as well as the body of evidence on environmental allergen exposure and how this can sensitize an individual. Given the link between skin barrier impairment, atopic dermatitis, food allergy, allergic asthma, and allergic rhinitis, it is logical that restoring the skin barrier and prevention or treating atopic dermatitis would have beneficial effects on prevention of related allergic diseases, particularly food allergy. We present the experimental and human studies that have evaluated this approach and discuss various factors which may influence the success of these approaches, such as the type of emollient chosen for the intervention, the role of managing skin inflammation, and differences between primary and secondary prevention of atopic dermatitis to achieve the desired outcome.

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“…Reasons for the inconsistency in results for moisturizer interventions might be due to different countries and cultures, different types of moisturizers, and differences in adherence. Dissanayake et al [18] performed an RCT in Japan to examine whether combined synbiotics and skin moisturizers could prevent AD and food allergy. However, they did not show e cacy of moisturizer application two to three times/day against prevention of AD and food allergy.…”

Section: Discussionmentioning

confidence: 99%

Effective Prevention of Atopic Dermatitis by Applying Fam’s Baby Moisturizer Twice Daily or Once Daily Compared with 2e Moisturizer Once Daily in High-Risk Neonates: Study Protocol for A Randomized, Blinded, Parallel, Three Group, Phase II Trial (PAF Study)

Inuzuka¹,

Yamamoto‐Hanada²,

Pak³

et al. 2020

Preprint

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BackgroundAtopic dermatitis (AD) is a chronic and inflammatory skin disease that commonly affects young children. AD causes health-related burdens associated with pruritus and poor quality of life. The efficacy of moisturizer application shows inconsistency on primary prevention of AD according to previous randomized, controlled trials. Which moisturizer is effective and how often moisturizer should be applied to prevent development of AD in infants remain unclear. We hypothesize that twice daily application of moisturizer using Fam’s Baby is more effective than once daily application and that a sufficient amount of moisturizer application is effective for preventing development of AD in neonates and infants. Therefore, this study aimed to examine whether applying Fam’s Baby twice daily or once daily prevents AD compared with 2e moisturizer once daily in neonates and infants with at least one parent or sibling who has had atopic dermatitis.MethodsThis study is a single-center, three-parallel group, assessor-blind, superiority, individually randomized, controlled, phase II trial. A newborn with at least one parent or sibling who has had AD is randomly assigned to application of Fam’s Baby twice daily, Fam’s Baby once daily, or 2e once daily in a 1:1:1 ratio until 32 weeks old. The primary outcome is the time to the first onset of AD during administration of the moisturizer.DiscussionThis is the first phase II randomized, controlled trial in Japan to investigate whether applying moisturizer (Fam’s Baby) twice daily or once daily can prevent the incidence of AD compared with another moisturizer (2e) once daily in high-risk neonates. In this study, we will use 2e once daily as control moisturizer to confirm the efficacy for primary prevention of AD as found in our previous trial. Evaluation of application of moisturizers for preventing AD in this study is expected to contribute to a reduction in the prevalence of AD and a reduction in health care costs. Trial registrationJapan Registry of Clinical Trials (jRCT); ID: jRCTs031200070. Registered on 20 July 2020.

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Skin Care and Synbiotics for Prevention of Atopic Dermatitis or Food Allergy in Newborn Infants: A 2 × 2 Factorial, Randomized, Non-Treatment Controlled Trial

Cited by 70 publications

References 21 publications

Preventing food allergy in infancy and childhood: Systematic review of randomised controlled trials

Preventing food allergy in infancy and childhood: Systematic review of randomised controlled trials

Epicutaneous sensitization in the development of food allergy: What is the evidence and how can this be prevented?

Effective Prevention of Atopic Dermatitis by Applying Fam’s Baby Moisturizer Twice Daily or Once Daily Compared with 2e Moisturizer Once Daily in High-Risk Neonates: Study Protocol for A Randomized, Blinded, Parallel, Three Group, Phase II Trial (PAF Study)

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