A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis
NCT ID: NCT07072273
Last Updated: 2025-11-28
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-11-17
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Probiotic Ointment
Twice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri
Probiotic Ointment
Ointment containing Lactobacillus reuteri
Interventions
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Probiotic Ointment
Ointment containing Lactobacillus reuteri
Eligibility Criteria
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Inclusion Criteria
SCORAD index between 20 and 50, inclusive.
Signed informed consent by parents or legal guardians.
Exclusion Criteria
Previous treatment with biologic agents or JAK inhibitors for AD.
Use of systemic corticosteroids within one month prior to inclusion in the clinical trial.
Use of topical corticosteroids within one month prior to inclusion in the clinical trial.
Use of conventional systemic immunosuppressants for AD (e.g., azathioprine, methotrexate, or cyclosporine) within three months prior to inclusion in the clinical trial.
Use of oral or topical probiotics within two months prior to inclusion in the clinical trial.
Use of topical or systemic antibiotics within one month prior to inclusion in the clinical trial.
Known hypersensitivity to the investigational product or any of its components.
Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial.
Fever at the start of treatment (axillary temperature \>37.5 °C or equivalent).
Diagnosed immunodeficiency disorders.
Current or past diagnosis of malignant neoplasms.
Any concurrent dermatologic or medical condition that, in the investigator's opinion, could interfere with the subject's response to treatment or require continuous use of topical corticosteroids.
Participation in other clinical research studies involving investigational products within one month prior to inclusion in the clinical trial.
6 Months
12 Years
ALL
No
Sponsors
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Bioithas SL
INDUSTRY
Biogaia New Sciences AB
INDUSTRY
Responsible Party
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Locations
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Belaneve Clinics
Alicante, , Spain
Centro Dermatológico Estético Alicante
Alicante, , Spain
Countries
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Central Contacts
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Other Identifiers
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BNS_RD_002
Identifier Type: -
Identifier Source: org_study_id
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