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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 design :
Inclusion visit at 20 weeks of gestation :
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREBIOTICS | Experimental | 188 pregnant women |
|
| PLACEBO | Placebo Comparator | 188 pregnant women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREBIOTICS | Dietary Supplement | women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| atopic dermatitis prevalence at M12 | prevalence will be evaluated according to UK party working group criteria | at 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| atopic dermatitis prevalence at M6 | prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire) | at 6 months of age |
| atopic dermatitis severity | evaluated by the SCORAD (Scoring Atopic Dermatitis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastien BARBAROT, Dr | Contact | (0)240084086 | +33 | sebastien.barbarot@chu-nantes.fr |
| Hélène AUBERT, Dr | Contact | helene.aubert@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Withdrawn | Angers | France | |||
| CHD Vendée |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250898 | Derived | 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. | |
| 31005913 |
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| PLACEBO | Other | women will daily take placebo (maltodextrin) from inclusion to delivery |
|
| at 12 months of age |
| atopic dermatitis severity | evaluated by the POEM (Patient Oriented Eczema Measure) | 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) | at 12 months of age |
| Tolerance of the prebiotics in mothers | evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...) | from inclusion to delivery |
| sensitization with the major allergens | skin prick tests | at 12 months of age |
| assessment of the Transepidermal Waterlos | evaluated by a TEWAMETER(R) | 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 | at 12 months of age |
| Not yet recruiting |
| La Roche-sur-Yon |
| France |
|
| CHU Nantes | Recruiting | Nantes | France |
|
| University Hospital | Recruiting | Rennes | France |
|
| Centre Hospitalo Universitaire | Recruiting | Toulouse | France |
|
| University Hospital | Recruiting | Tours | France |
|
| 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. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
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