Eczema breakthrough? postbiotic cream may keep Kids' skin calm
NCT ID NCT06474728
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a moisturizer containing postbiotic Saccharomyces and Lactobacillus can reduce the risk of eczema returning in children aged 0-6 years who are in remission. 98 children used either the special emollient or a standard one for 12 weeks. The goal was to see if the postbiotic cream could keep flare-ups away better than routine care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- emollient containing postbiotic Saccharomyces and Lactobacillus
- What this could lead to
- If it works, this could offer a natural way to prevent eczema flare-ups in young children without strong medications.
- What could go wrong
- This is a small, completed trial with 98 children, and the results may not apply to all cases. The effect may be modest or no better than standard moisturizers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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98 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 6 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must meet the diagnostic criteria established by Williams. 2. Moderate atopic dermatitis is defined by an Eczema Area and Severity Index (EASI) score of 7.1 to 21.0, and an Investigator's Global Assessment (IGA) score of 3. 3. Age range is 0 to 6 years, with no gender restrictions. 4. Guardians of the participants must be willing to apply the test product to the participants as directed by the physician throughout the study period. 5. Participants should not have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines. 6. Within 4 weeks prior to enrollment, participants should not have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, nor should they have used systemic corticosteroids or systemic antihistamines. 7. Participants are not allowed to use other similar products during the entire study period. 8. Prior to the commencement of any study-specific examination or procedural step, participants must sign an informed consent form. For infants and young children aged 0 to 6 years, the guardians must sign an informed consent waiver on behalf of the child and also sign a parental version of the informed consent form. Exclusion Criteria: 1. Do not meet the diagnostic criteria established by Williams. 2. Children with acute exacerbation characterized by erosion, exudation, or secondary infection. 3. Presence of open skin infections (bacterial, viral, or fungal) at the application site. 4. Children currently participating in other clinical studies or having participated within the last 3 months. 5. Children who have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines. 6. Children who have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, systemic corticosteroids, or systemic antihistamines within 4 weeks prior to enrollment. 7. Children with severe immune system disorders (such as lymphoma, AIDS, Wiskott-Aldrich syndrome) or a history of malignant tumors. 8. Children with severe heart, liver, or kidney diseases. 9. Children with other skin diseases in the treatment area besides atopic dermatitis. 10. Known allergy to hydrocortisone butyrate cream or the test product. 11. Poor compliance of the subject, known inability to attend visits on time, or unwillingness to comply with the study protocol during the study period. 12. Any condition or previous/concurrent treatment that makes the subject ineligible for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Dermatology,Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
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