Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
126 participants
INTERVENTIONAL
2022-05-24
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tested formula LP-2018
infant formula containing fibers
tested formula with fiber
formula containing fibers
Placebo formula CT-2018
infant formula without fibers
Control
formula without fiber
Interventions
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tested formula with fiber
formula containing fibers
Control
formula without fiber
Eligibility Criteria
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Inclusion Criteria
* Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0
* Whose parents gave their informed consent
Exclusion Criteria
* antihistamine
* use of dermocorticoide and/or antibiotics within 15 days
* symptoms of cutaneous infection
* Past anaphylactic shock
* cow's milk, soya or fish allergy
* Exclusive or predominant breast feediing (more than one feeding/day)
* Consumption of less than 500 ml per day
* Participation to another trial.
1 Month
18 Months
ALL
No
Sponsors
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United Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Fabienne Cahn-Sellem
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Sebastien Barbarot
Role: STUDY_CHAIR
Hotel Dieu Hospital, Nantes, France
Elena Bradatan
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Locations
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Center_13
Namur, , Belgium
Center_14
Thuin, , Belgium
Center_05
Nice, , France
Countries
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Other Identifiers
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UP2018-EFITOP
Identifier Type: -
Identifier Source: org_study_id