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

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Dermatitis, Atopic

Treatments: Dietary Supplement: PREBIOTICS; Other: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT03183440

RC16_0012

Details and patient eligibility

About

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 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

Enrollment: 376 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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376 participants in 2 patient groups, including a placebo group

PREBIOTICS

Experimental group

Description:

188 pregnant women

Treatment:

Dietary Supplement: PREBIOTICS

PLACEBO

Placebo Comparator group

Description:

188 pregnant women

Treatment:

Other: PLACEBO