Dermatitis, Atopic
Conditions
Keywords
Atopic dermatitis, Prevention, Prebiotics, Pregnancy
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
Interventions
DIETARY_SUPPLEMENTPREBIOTICS
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
OTHERPLACEBO
women will daily take placebo (maltodextrin) from inclusion to delivery
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| atopic dermatitis prevalence at M12 | at 12 months of age | prevalence will be evaluated according to UK party working group criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| atopic dermatitis severity | at 12 months of age | evaluated by the SCORAD (Scoring Atopic Dermatitis) |
| 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) |
| Tolerance of the prebiotics in mothers | from inclusion to delivery | evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...) |
| atopic dermatitis prevalence at M6 | at 6 months of age | prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire) |
| assessment of the Transepidermal Waterlos | at J1 and at 12 months of age | evaluated by a TEWAMETER(R) |
| 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 |
Countries
France
Contacts
Primary ContactSebastien BARBAROT, Dr
Backup ContactHélène AUBERT, Dr
Outcome results
None listed