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

Study Overview
=================
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

Official Title
-----------------
A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Dietary Supplement: PREBIOTICS
* Other: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREBIOTICS<br>188 pregnant women | Dietary Supplement: PREBIOTICS<br>* women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery<br>|
| Placebo Comparator: PLACEBO<br>188 pregnant women | Other: PLACEBO<br>* women will daily take placebo (maltodextrin) from inclusion to delivery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atopic dermatitis prevalence at M12 | prevalence will be evaluated according to UK party working group criteria | at 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atopic dermatitis prevalence at M6 | prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire) | at 6 months of age | 
| atopic dermatitis severity | evaluated by the SCORAD (Scoring Atopic Dermatitis) | at 12 months of age | 
| atopic dermatitis severity | evaluated by the POEM (Patient Oriented Eczema Measure) | 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) | at 12 months of age | 
| Tolerance of the prebiotics in mothers | evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...) | from inclusion to delivery | 
| sensitization with the major allergens | skin prick tests | at 12 months of age | 
| assessment of the Transepidermal Waterlos | evaluated by a TEWAMETER(R) | 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 | at 12 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, Prevention, Prebiotics, Pregnancy