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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2023

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 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

Arms, Groups and Cohorts

  • Experimental: PREBIOTICS
    • 188 pregnant women
  • Placebo Comparator: PLACEBO
    • 188 pregnant women

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Sebastien BARBAROT, Dr, (0)240084086, sebastien.barbarot@chu-nantes.fr

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