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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)

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ClinicalTrials.gov Identifier: NCT03183440
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Dietary Supplement: PREBIOTICS Other: PLACEBO Not Applicable

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
  • prevalence of AD
  • skin prick tests
  • FDQLI score
  • assessment of the Transepidermal Waterlos evaluated by a TEWAMETER

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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.
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Inulin

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




Primary Outcome Measures :
  1. atopic dermatitis prevalence at M12 [ Time Frame: at 12 months of age ]
    prevalence will be evaluated according to UK party working group criteria


Secondary Outcome Measures :
  1. atopic dermatitis prevalence at M6 [ Time Frame: at 6 months of age ]
    prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)

  2. atopic dermatitis severity [ Time Frame: at 12 months of age ]
    evaluated by the SCORAD (Scoring Atopic Dermatitis)

  3. atopic dermatitis severity [ Time Frame: at 12 months of age ]
    evaluated by the POEM (Patient Oriented Eczema Measure)

  4. 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)

  5. Tolerance of the prebiotics in mothers [ Time Frame: from inclusion to delivery ]
    evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)

  6. sensitization with the major allergens [ Time Frame: at 12 months of age ]
    skin prick tests

  7. assessment of the Transepidermal Waterlos [ Time Frame: at J1 and at 12 months of age ]
    evaluated by a TEWAMETER(R)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183440


Contacts
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Contact: Sebastien BARBAROT, Dr (0)240084086 ext +33 sebastien.barbarot@chu-nantes.fr
Contact: Hélène AUBERT, Dr helene.aubert@chu-nantes.fr

Locations
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France
CHU Angers Withdrawn
Angers, France
CHD Vendée Not yet recruiting
La Roche Sur Yon, France
Contact: Guillaume DUCARME       guillaume.ducarme@chd-vendee.fr   
Sub-Investigator: Marion FENOT         
Sub-Investigator: Carole POIRAUD         
Principal Investigator: Guillaume DUCARME         
CHU Nantes Recruiting
Nantes, France
Contact: Vincent DOCHEZ         
University Hospital Recruiting
Rennes, France
Principal Investigator: Linda LASSEL, MD         
Centre Hospitalo Universitaire Not yet recruiting
Toulouse, France
Contact: Mathieu MORIN         
Principal Investigator: Mathieu MORIN         
University Hospital Recruiting
Tours, France
Principal Investigator: Franck PERROTIN, Pr         
Sponsors and Collaborators
Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03183440    
Other Study ID Numbers: RC16_0012
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Atopic dermatitis
Prevention
Prebiotics
Pregnancy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases