Dermatitis, AtopicPREGRALLNCT03183440
Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children
A study testing PREBIOTICS in people with Dermatitis, Atopic, run by Nantes University Hospital at 6 sites in France.
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%). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- PREBIOTICS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 6 sitesFrance
- Study dates
- 13 Feb 2018to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
Hélène AUBERT, Dr contact
6 sites in 1 country
France6 sites, 5 recruiting
- Withdrawn
CHU Angers
Angers
- Not yet recruiting
CHD Vendée
La Roche-sur-Yon
Guillaume DUCARME, guillaume.ducarme@chd-vendee.fr
Marion FENOT
- Recruiting
CHU Nantes
Nantes
Vincent DOCHEZ
- Recruiting
University Hospital
Rennes
Linda LASSEL, MD
- Recruiting
Centre Hospitalo Universitaire
Toulouse
Delphine DUCHANOIS
Delphine DUCHANOIS
- Recruiting
University Hospital
Tours
Franck PERROTIN, Pr
About this study
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.
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.
Read the 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
- Conditions
- Dermatitis, Atopic
- Being tested
- PREBIOTICS, PLACEBO
- Keywords
- Atopic dermatitis, Prevention, Prebiotics, Pregnancy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREBIOTICSDietary supplement
women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
PLACEBOOther
women will daily take placebo (maltodextrin) from inclusion to delivery
| Study group | Role | What they receive |
|---|---|---|
| PREBIOTICS | Experimental | 188 pregnant women Receives: Dietary Supplement: PREBIOTICS |
| PLACEBO | Placebo comparator | 188 pregnant women Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
atopic dermatitis prevalence at M12
prevalence will be evaluated according to UK party working group criteria
Measured: at 12 months of age
Secondary outcomes (8)
atopic dermatitis prevalence at M6
prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)
Measured: at 6 months of age
atopic dermatitis severity
evaluated by the SCORAD (Scoring Atopic Dermatitis)
Measured: at 12 months of age
atopic dermatitis severity
evaluated by the POEM (Patient Oriented Eczema Measure)
Measured: at 12 months of age
Quality of life of the child and his/her family
evaluated by the FDQLI score (Family Dermatitis Quality of life Index)
Measured: at 12 months of age
Tolerance of the prebiotics in mothers
evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)
Measured: from inclusion to delivery
sensitization with the major allergens
skin prick tests
Measured: at 12 months of age
assessment of the Transepidermal Waterlos
evaluated by a TEWAMETER(R)
Measured: at J1 and at 12 months of age
food allergies prevalence at M12
Prevalence will be evaluated by recording food allergies diagnosed by a physician
Measured: at 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start13 Feb 2018
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183440
- Sponsor's protocol ID
- RC16_0012
- Acronym
- PREGRALL
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2017
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 Feb 18;194(3):441-449. doi: 10.1093/bjd/ljaf414.
PubMed 41250898Cabridain 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.
PubMed 31005913
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03183440
- Acronym / sponsor ID
- PREGRALL / RC16_0012
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic dermatitis, Prevention, Prebiotics, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREBIOTICS | Experimental | Dietary Supplement: PREBIOTICS188 pregnant women |
| PLACEBO | Placebo comparator | Other: PLACEBO188 pregnant women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREBIOTICSwomen will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery | Dietary supplement | PREBIOTICS |
| PLACEBOwomen will daily take placebo (maltodextrin) from inclusion to delivery | Other | PLACEBO |
Primary outcome
atopic dermatitis prevalence at M12
Time frame: at 12 months of age
prevalence will be evaluated according to UK party working group criteria
8 secondary outcomes
atopic dermatitis prevalence at M6
Time frame: at 6 months of age
atopic dermatitis severity
Time frame: at 12 months of age
atopic dermatitis severity
Time frame: at 12 months of age
Quality of life of the child and his/her family
Time frame: at 12 months of age
Tolerance of the prebiotics in mothers
Time frame: from inclusion to delivery
sensitization with the major allergens
Time frame: at 12 months of age
assessment of the Transepidermal Waterlos
Time frame: at J1 and at 12 months of age
food allergies prevalence at M12
Time frame: at 12 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Derived from this study: PubMed 41250898Barbarot 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. 2026 Feb 18;194(3):441-449. doi: 10.1093/bjd/ljaf414.
- Derived from this study: PubMed 31005913Cabridain 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène AUBERT, Dr contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREBIOTICS in people with Dermatitis, Atopic, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastien BARBAROT, Dr ((0)240084086 ext. +33, sebastien.barbarot@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atopic dermatitis prevalence at M12 (time frame: at 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183440, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.