Clinical trial NCT03183440: Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Atopic dermatitis
Prevention
Prebiotics
Pregnancy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 376
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: atopic dermatitis prevalence at M12
timeFrame: at 12 months of age
Secondary outcomes:
measure: atopic dermatitis prevalence at M6
timeFrame: at 6 months of age
measure: atopic dermatitis severity
timeFrame: at 12 months of age
measure: atopic dermatitis severity
timeFrame: at 12 months of age
measure: Quality of life of the child and his/her family
timeFrame: at 12 months of age
measure: Tolerance of the prebiotics in mothers
timeFrame: from inclusion to delivery
measure: sensitization with the major allergens
timeFrame: at 12 months of age
measure: assessment of the Transepidermal Waterlos
timeFrame: at J1 and at 12 months of age
measure: food allergies prevalence at M12
timeFrame: at 12 months of age
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU Nantes
city: Rennes
country: France
facility: University Hospital
city: Toulouse
country: France
facility: Centre Hospitalo Universitaire
city: Tours
country: France
facility: University Hospital
Study officials:
References:
citation: Cabridain C, Aubert H, Kaeffer B, Badon V, Boivin M, Dochez V, Winer N, Faurel-Paul E, Planche L, Riochet D, Maruani A, Perrotin F, Droitcourt C, Lassel L, Tching-Sin M, Rogers NK, Bodinier M, Barbarot S. 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. BMJ Open. 2019 Apr 20;9(4):e024974. doi: 10.1136/bmjopen-2018-024974.