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

Primary Purpose

Dermatitis, Atopic

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PREBIOTICS
PLACEBO
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatitis, Atopic focused on measuring Atopic dermatitis, Prevention, Prebiotics, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU Angers
  • CHD Vendée
  • CHU NantesRecruiting
  • University HospitalRecruiting
  • Centre Hospitalo UniversitaireRecruiting
  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PREBIOTICS

PLACEBO

Arm Description

188 pregnant women

188 pregnant women

Outcomes

Primary Outcome Measures

atopic dermatitis prevalence at M12
prevalence will be evaluated according to UK party working group criteria

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2017
Last Updated
June 11, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03183440
Brief Title
Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Atopic dermatitis, Prevention, Prebiotics, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREBIOTICS
Arm Type
Experimental
Arm Description
188 pregnant women
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
188 pregnant women
Intervention Type
Dietary Supplement
Intervention Name(s)
PREBIOTICS
Intervention Description
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
women will daily take placebo (maltodextrin) from inclusion to delivery
Primary Outcome Measure Information:
Title
atopic dermatitis prevalence at M12
Description
prevalence will be evaluated according to UK party working group criteria
Time Frame
at 12 months of age
Secondary Outcome Measure Information:
Title
atopic dermatitis prevalence at M6
Description
prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)
Time Frame
at 6 months of age
Title
atopic dermatitis severity
Description
evaluated by the SCORAD (Scoring Atopic Dermatitis)
Time Frame
at 12 months of age
Title
atopic dermatitis severity
Description
evaluated by the POEM (Patient Oriented Eczema Measure)
Time Frame
at 12 months of age
Title
Quality of life of the child and his/her family
Description
evaluated by the FDQLI score (Family Dermatitis Quality of life Index)
Time Frame
at 12 months of age
Title
Tolerance of the prebiotics in mothers
Description
evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)
Time Frame
from inclusion to delivery
Title
sensitization with the major allergens
Description
skin prick tests
Time Frame
at 12 months of age
Title
assessment of the Transepidermal Waterlos
Description
evaluated by a TEWAMETER(R)
Time Frame
at J1 and at 12 months of age
Title
food allergies prevalence at M12
Description
Prevalence will be evaluated by recording food allergies diagnosed by a physician
Time Frame
at 12 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastien BARBAROT, Dr
Phone
(0)240084086
Ext
+33
Email
sebastien.barbarot@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène AUBERT, Dr
Email
helene.aubert@chu-nantes.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Withdrawn
Facility Name
CHD Vendée
City
La Roche Sur Yon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume DUCARME
Email
guillaume.ducarme@chd-vendee.fr
First Name & Middle Initial & Last Name & Degree
Marion FENOT
First Name & Middle Initial & Last Name & Degree
Carole POIRAUD
First Name & Middle Initial & Last Name & Degree
Guillaume DUCARME
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent DOCHEZ
Facility Name
University Hospital
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda LASSEL, MD
Facility Name
Centre Hospitalo Universitaire
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine DUCHANOIS
First Name & Middle Initial & Last Name & Degree
Delphine DUCHANOIS
Facility Name
University Hospital
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck PERROTIN, Pr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31005913
Citation
Cabridain C, Aubert H, Kaeffer B, Badon V, Boivin M, Dochez V, Winer N, Faurel-Paul E, Planche L, Riochet D, Maruani A, Perrotin F, Droitcourt C, Lassel L, Tching-Sin M, Rogers NK, Bodinier M, Barbarot S. Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e024974. doi: 10.1136/bmjopen-2018-024974.
Results Reference
derived

Learn more about this trial

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

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