A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis (NCT07072273) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis
Spain40 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range
6 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
History of phototherapy for the treatment of AD.
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 conditi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks