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

June 11, 2021 updated by: Nantes University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Withdrawn
        • CHU Angers
      • La Roche Sur Yon, France
        • Not yet recruiting
        • CHD Vendée
        • Contact:
        • Sub-Investigator:
          • Marion FENOT
        • Principal Investigator:
          • Guillaume DUCARME
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Vincent DOCHEZ
      • Rennes, France
        • Recruiting
        • University Hospital
        • Principal Investigator:
          • Linda LASSEL, MD
      • Toulouse, France
        • Recruiting
        • Centre Hospitalo Universitaire
        • Contact:
          • Delphine DUCHANOIS
        • Principal Investigator:
          • Delphine DUCHANOIS
      • Tours, France
        • Recruiting
        • University Hospital
        • Principal Investigator:
          • Franck PERROTIN, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PREBIOTICS
188 pregnant women
Dietary supplement: PREBIOTICS
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
Placebo Comparator: PLACEBO
188 pregnant women
Other: PLACEBO
women will daily take placebo (maltodextrin) from inclusion to delivery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC16_0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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