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

Dermatitis, Atopic Clinical Trial

— PREGRALL  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183440
• Other study ID #: RC16_0012
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 2023

Study information

• Verified date: June 2021
• Source: Nantes University Hospital
• Contact: Sebastien BARBAROT, Dr
• Phone: (0)240084086
• Email: sebastien.barbarot[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHD Vendée	La Roche Sur Yon
France	CHU Nantes	Nantes
France	University Hospital	Rennes
France	Centre Hospitalo Universitaire	Toulouse
France	University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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