Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.
Study design : Inclusion visit at 20 weeks of gestation : * randomization * start of supplementation (GOS/inulin or placebo) Phone call at 24 weeks of gestation : * checking tolerance * checking observance 32 weeks of gestation visit : * replenishment of prebiotics * collect of AE Day 1 : assessment of the Transepidermal Waterlos evaluated by a TEWAMETER Delivery/per partum Visit At M3 : The national recommendations for the dietary diversification of the child will be transmitted to the patients At M6 : evaluation of AD prevalence by parents At M12 : Pediatric dermatology consultation * clinical exam of child * the SCORAD * the POEM questionnaire * prevalence of AD * skin prick tests * FDQLI score * assessment of the Transepidermal Waterlos evaluated by a TEWAMETER * prevalence of food allergies
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
376
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
women will daily take placebo (maltodextrin) from inclusion to delivery
CHU Angers
Angers, France
WITHDRAWNCHD Vendée
La Roche-sur-Yon, France
NOT_YET_RECRUITINGCHU Nantes
Nantes, France
RECRUITINGUniversity Hospital
Rennes, France
RECRUITINGCentre Hospitalo Universitaire
Toulouse, France
RECRUITINGUniversity Hospital
Tours, France
RECRUITINGatopic dermatitis prevalence at M12
prevalence will be evaluated according to UK party working group criteria
Time frame: at 12 months of age
atopic dermatitis prevalence at M6
prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)
Time frame: at 6 months of age
atopic dermatitis severity
evaluated by the SCORAD (Scoring Atopic Dermatitis)
Time frame: at 12 months of age
atopic dermatitis severity
evaluated by the POEM (Patient Oriented Eczema Measure)
Time frame: at 12 months of age
Quality of life of the child and his/her family
evaluated by the FDQLI score (Family Dermatitis Quality of life Index)
Time frame: at 12 months of age
Tolerance of the prebiotics in mothers
evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)
Time frame: from inclusion to delivery
sensitization with the major allergens
skin prick tests
Time frame: at 12 months of age
assessment of the Transepidermal Waterlos
evaluated by a TEWAMETER(R)
Time frame: at J1 and at 12 months of age
food allergies prevalence at M12
Prevalence will be evaluated by recording food allergies diagnosed by a physician
Time frame: at 12 months of age
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