Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children
PREGRALL
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.
1 other identifier
interventional
376
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJune 16, 2021
June 1, 2021
5.5 years
June 8, 2017
June 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
atopic dermatitis prevalence at M12
prevalence will be evaluated according to UK party working group criteria
at 12 months of age
Secondary Outcomes (8)
atopic dermatitis prevalence at M6
at 6 months of age
atopic dermatitis severity
at 12 months of age
atopic dermatitis severity
at 12 months of age
Quality of life of the child and his/her family
at 12 months of age
Tolerance of the prebiotics in mothers
from inclusion to delivery
- +3 more secondary outcomes
Study Arms (2)
PREBIOTICS
EXPERIMENTAL188 pregnant women
PLACEBO
PLACEBO COMPARATOR188 pregnant women
Interventions
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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, France
Related Publications (2)
Barbarot S, Aubert H, Boivin M, Foureau A, Maruani A, Droitcourt C, Mazereeuw-Hautier J, Faurel-Paul E, Le Thuaut A, Tching-Sin M, Dochez V, Brosseau C, Bodinier M. Evaluation of antenatal prebiotic intake in infants at risk of atopy: the double-blind PREGRALL randomized clinical trial. Br J Dermatol. 2025 Nov 18:ljaf414. doi: 10.1093/bjd/ljaf414. Online ahead of print.
PMID: 41250898DERIVEDCabridain 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.
PMID: 31005913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 12, 2017
Study Start
February 13, 2018
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
June 16, 2021
Record last verified: 2021-06