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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prebiotics in Prevention of Atopy

NCT02116452

Atopic Dermatitis

COMPLETED PHASE3

Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis

NCT04182425

Dermatitis, Allergic Contact Infectious Diseases

COMPLETED

Prebiotic in Preterm Infants

NCT03306316

Preterm Infant Development, Infant Nutrition

COMPLETED NA

Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

NCT01603719

Infections Stool Flora Stool Biochemistry +2 more

COMPLETED NA

Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

NCT04962594

Healthy Infants

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dermatitis, Atopic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PREBIOTICS

188 pregnant women

Group Type EXPERIMENTAL

PREBIOTICS

Intervention Type DIETARY_SUPPLEMENT

women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery

PLACEBO

188 pregnant women

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

women will daily take placebo (maltodextrin) from inclusion to delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PREBIOTICS

women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

women will daily take placebo (maltodextrin) from inclusion to delivery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No