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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- STATUS
- Recruiting
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- End date
- Aug 26, 2023
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- participants needed
- 376
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- sponsor
- Nantes University Hospital
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.
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
Details
| Condition | Dermatitis, Atopic |
|---|---|
| Treatment | Placebo, Prebiotics |
| Clinical Study Identifier | NCT03183440 |
| Sponsor | Nantes University Hospital |
| Last Modified on | 1 March 2022 |
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