A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis
Open-label Clinical Trial Evaluating an Emollient With Lactobacillus Reuteri for the Treatment of Pediatric Atopic Dermatitis
1 other identifier
interventional
40
1 country
2
Brief Summary
The goal of this study is to evaluate the efficacy of the emollient topical formulation containing Lactobacillus reuteri in improving atopic dermatitis symptoms in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Start
First participant enrolled
November 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedNovember 28, 2025
November 1, 2025
6 months
July 9, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
8 weeks
Secondary Outcomes (4)
Change in SCORing Atopic Dermatitis (SCORAD) after 1 week
1 week
Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks
4 weeks
Change in POEM
1, 4 and 8 weeks
Change in PIQoL-AD
8 weeks
Other Outcomes (3)
Microbiota composition
Baseline and 8 weeks
Microbiota composition
Baseline and 8 weeks
Adverse Events
8 weeks
Study Arms (1)
Probiotic Ointment
EXPERIMENTALTwice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients of both sexes, aged between 6 months and 12 years, with a confirmed diagnosis of AD based on Hanifin and Rajka criteria (ANNEX VIII).
- SCORAD index between 20 and 50, inclusive.
- Signed informed consent by parents or legal guardians.
You may not qualify if:
- History of phototherapy for the treatment of AD.
- Previous treatment with biologic agents or JAK inhibitors for AD.
- Known hypersensitivity to the investigational product or any of its components.
- Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogaia New Sciences ABlead
- Bioithas SLcollaborator
Study Sites (2)
Belaneve Clinics
Alicante, Spain
Centro Dermatológico Estético Alicante
Alicante, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 18, 2025
Study Start
November 17, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
November 28, 2025
Record last verified: 2025-11