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Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk
Clémentine Cabridain1, Hélène Aubert2, Bertrand Kaeffer3
1UMR PhAN, INRA Centre Angers-Nantes, Nantes, Pays de la Loire, France.
Insights
Maternal prebiotic supplementation during pregnancy may prevent atopic dermatitis (AD) in high-risk infants. This study investigated antenatal prebiotic intake to reduce AD occurrence in children.
Area of Science:
- Immunology
- Microbiology
- Pediatrics
Background:
- Atopic dermatitis (AD) affects 10%-15% of European children, necessitating novel primary preventive strategies.
- Disrupted gut microbiota in early life is linked to atopic diseases, suggesting microbial interventions could be beneficial.
- Prenatal development is critical for establishing immune tolerance, making antenatal interventions a promising area of research.
Purpose of the Study:
- To evaluate the effectiveness of antenatal maternal prebiotic supplementation in preventing AD in high-risk children.
- To assess the impact of galacto-oligosaccharide/inulin on AD occurrence at one year of age.
- To explore secondary outcomes including AD severity, quality of life, and prebiotic tolerance.
Main Methods:
- A randomized, multicenter, double-blind trial involving 376 pregnant women with a history of atopic disease.
- Maternal supplementation with prebiotics (galacto-oligosaccharide/inulin) or placebo (maltodextrin) from 20 weeks gestation until delivery.
- Primary outcome: prevalence of AD at one year of age, assessed using optimized UK Working Party Diagnostic Criteria.
Main Results:
- This is a pre-results study; final results are pending.
- The study is powered to detect a 33% reduction in AD risk with 80% power.
- Data analysis will follow the intention-to-treat principle.
Conclusions:
- Antenatal prebiotic supplementation represents a potential novel strategy for primary prevention of atopic dermatitis.
- Further research is warranted to confirm the efficacy and safety of this intervention.
- The findings will be disseminated through peer-reviewed publications and conference presentations.
Introduction:
Atopic dermatitis (AD) is a chronic inflammatory disease affecting 10%-15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial 'balance' in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host's health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.
Methods And Analysis:
This is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks' gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle.
Ethics And Dissemination:
Results will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of 'Comité de Protection des Personnes Sud Ouest-Outre-Mer III' of the University Hospital Centre of Bordeaux (2017/13).
Trial Registration Number:
NCT03183440; Pre-results.
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