NCT03183440

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PREBIOTICS	women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
OTHER	PLACEBO	women will daily take placebo (maltodextrin) from inclusion to delivery

Timeline

• Start date: 2018-02-13
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2017-06-12
• Last updated: 2021-06-16

Locations

6 sites across 1 country: France