Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children

Not Applicable

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Inclusion Criteria

pregnant women with an eutocic pregnancy before 20 weeks of gestation
women with personal history of atopy diagnosed by a healthcare Professional
Women accepting a complete avoidance of dietary supplements containing prebiotics or probiotics during study supplementation
women accepting dermato-pediatric follow-up during the first year of life of the new-born (Phone calls at 24 weeks of gestation and 6 months of child and a consultation at 12 months of age)
non Tobacco user women
women over 18 years
women without history of severe gestational diabetes

Exclusion Criteria

women not giving up on intake of dietary supplements containing prebiotics or probiotics during study supplementation
women refusing dermato-pediatric follow-up during the first year of the newborn
ongoing allergy and/or intolerance to cow's milk proteins
term >21 weeks of gestation

Arm && Interventions

Group	Intervention	Description
PLACEBO	PLACEBO	188 pregnant women
PREBIOTICS	PREBIOTICS	188 pregnant women

Primary Outcome Measures

Name	Time	Method
atopic dermatitis prevalence at M12	at 12 months of age	prevalence will be evaluated according to UK party working group criteria

Secondary Outcome Measures

Name	Time	Method
atopic dermatitis severity	at 12 months of age	evaluated by the POEM (Patient Oriented Eczema Measure)
food allergies prevalence at M12	at 12 months of age	Prevalence will be evaluated by recording food allergies diagnosed by a physician
sensitization with the major allergens	at 12 months of age	skin prick tests
Quality of life of the child and his/her family	at 12 months of age	evaluated by the FDQLI score (Family Dermatitis Quality of life Index)
atopic dermatitis prevalence at M6	at 6 months of age	prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)
Tolerance of the prebiotics in mothers	from inclusion to delivery	evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)
assessment of the Transepidermal Waterlos	at J1 and at 12 months of age	evaluated by a TEWAMETER(R)

Locations (5): CHU Nantes
🇫🇷
Nantes, France
CHD Vendée
🇫🇷
La Roche Sur Yon, France
CHU Angers
🇫🇷
Angers, France
University Hospital
🇫🇷
Tours, France
Centre Hospitalo Universitaire
🇫🇷
Toulouse, France