Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial
| Autor: | Linda Lassel, Marion Boivin, Lucie Planche, Sébastien Barbarot, Vincent Dochez, Bertrand Kaeffer, Virginie Badon, Martine Tching-Sin, Clémentine Cabridain, Catherine Droitcourt, Marie Bodinier, Norbert Winer, Annabel Maruani, Franck Perrotin, David Riochet, Elodie Faurel-Paul, Hélène Aubert, Natasha K Rogers |
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| Přispěvatelé: | Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), University of Nottingham, UK (UON), Unité de recherche sur les Biopolymères, Interactions Assemblages (BIA), Institut National de la Recherche Agronomique (INRA), Agence Nationale de la RechercheAgence Nationale de la Recherche, Ministère des Affaires Sociales et de la SantéMinistère des Affaires Sociales et de la Santé, Physiologie des Adaptations Nutritionnelles [UMR_A1280] (PhAN), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), CIC Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Université de Nantes (UN)-Institut National de la Recherche Agronomique (INRA), Jonchère, Laurent |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics medicine.medical_treatment [SDV]Life Sciences [q-bio] Psychological intervention law.invention 0302 clinical medicine Randomized controlled trial Quality of life Pregnancy law Protocol Multicenter Studies as Topic 030212 general & internal medicine Randomized Controlled Trials as Topic Prenatal Care General Medicine Atopic dermatitis 3. Good health [SDV] Life Sciences [q-bio] dermatology Treatment Outcome Alimentation et Nutrition Gestation eczema paediatric dermatology Female medicine.medical_specialty Médecine humaine et pathologie Placebo Dermatitis Atopic 03 medical and health sciences Double-Blind Method medicine Humans Food and Nutrition business.industry Prebiotic Infant Newborn Infant Maternal Nutritional Physiological Phenomena medicine.disease Clinical trial Prebiotics Dietary Supplements Human health and pathology Pregnant Women business 030217 neurology & neurosurgery |
| Zdroj: | BMJ OPEN 4 (9), e024974. (2019) BMJ Open BMJ Open, BMJ Publishing Group, 2019, 9 (4), pp.e024974. ⟨10.1136/bmjopen-2018-024974⟩ BMJ Open, 2019, 9 (4), pp.e024974. ⟨10.1136/bmjopen-2018-024974⟩ |
| ISSN: | 0318-3440 2044-6055 |
| Popis: | IntroductionAtopic 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 analysisThis 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 disseminationResults 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 numberNCT03183440; Pre-results. |
| Databáze: | OpenAIRE |
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