Atopic DermatitisNCT07072273
A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis
A study testing Probiotic Ointment in people with Atopic Dermatitis, run by Biogaia New Sciences AB at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Probiotic Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 17 Nov 2025to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Belaneve Clinics
Alicante
Centro Dermatológico Estético Alicante
Alicante
About this study
Official title: Open-label Clinical Trial Evaluating an Emollient With Lactobacillus Reuteri for the Treatment of Pediatric Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Probiotic Ointment
- Keywords
- AD, Atopic Dermatitis, probiotic, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic OintmentOther
Ointment containing Lactobacillus reuteri
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Ointment | Experimental | Twice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri Receives: Other: Probiotic Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (4)
Change in SCORing Atopic Dermatitis (SCORAD) after 1 week
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 1 week of treatment with the topical emollient formulation containing Lactobacillus reuteri
Measured: 1 week
Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 4 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
Measured: 4 weeks
Change in POEM
Change in POEM score from baseline after 1, 4, and 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
Measured: 1, 4 and 8 weeks
Change in PIQoL-AD
Change in PIQoL-AD score from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start17 Nov 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogaia New Sciences AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioithas SL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072273
- Sponsor's protocol ID
- BNS_RD_002
- Status last verified
- May 2026
- First submitted
- 9 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Clinical Trial Evaluating an Emollient With Lactobacillus Reuteri for the Treatment of Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07072273
- Acronym / sponsor ID
- BNS_RD_002
- Conditions
- Atopic Dermatitis
- Keywords
- AD, Atopic Dermatitis, probiotic, Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biogaia New Sciences ABIndustry (pharma, biotech, devices)
- Collaborators
- Bioithas SL
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Ointment | Experimental | Other: Probiotic OintmentTwice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic OintmentOintment containing Lactobacillus reuteri | Other | Probiotic Ointment |
Primary outcome
Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks
Time frame: 8 weeks
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
4 secondary outcomes
Change in SCORing Atopic Dermatitis (SCORAD) after 1 week
Time frame: 1 week
Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks
Time frame: 4 weeks
Change in POEM
Time frame: 1, 4 and 8 weeks
Change in PIQoL-AD
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Ointment in people with Atopic Dermatitis, run by Biogaia New Sciences AB at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.