Atopic DermatitisNCT05443490
Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children
A study testing Probiotic mixture with three bacterial strains with maltodextrin as a carrier. in people with Atopic Dermatitis, run by Bionou Research, S.L. at 3 sites in 3 countries.
Trial summary
A prospective case-control multicentric pilot study of 12 weeks duration to evaluate the effect of a probiotic mixture in the treatment of atopic dermatitis in children from 0 to 3 years old, by measuring the severity of the condition using the SCORAD index, as well as the Clinical Global Impression rating scale, the… Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 Feb 2023to 22 Jun 2023
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signature of informed consent from the parent / legal guardian of the patient.
- Patients with mild-moderate atopic dermatitis (SCORAD >20).
- Age between 6 months and 3 years old, both inclusive (36 months).
- Patients using topical corticosteroids.
- Diagnosis of atopic dermatitis.
Who cannot join
- In treatment with phototherapy for atopic dermatitis in the previous 2 months
- In treatment with systemic corticosteroids in the previous month.
- In treatment with immunosuppressants or cytostatics in the previous 2 months.
- Those who have received probiotic treatment in the previous month.
- Those who have been treated with systemic antibiotics in the previous two weeks.
- Patients with axillary or oral temperature > 37.5ºC; or rectal or otic temperature > 38ºC.
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- Patients with severe allergic diseases.
- Patients with pathologies related to immunodeficiency or cancer processes.
- Patients with other dermatological pathologies that may make it difficult to assess atopic dermatitis or require the continued use of topical corticosteroids.
- Patients in whom any of the products under study is contraindicated as established in their technical specifications.
- Patients who have participated in drug research studies in the previous 3 months
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Bolivia1 site
Hospital del niño Dr. Ovidio Aliaga Uria y Hospital Arco Iris
La Paz, La Paz Department, 10097
Costa Rica1 site
Centro de Especialidades Dermatológicas Ac S.A (Dermaláser)
San José, Provincia de San José, Sabana Oeste, T. Médica 20/20
About this study
Official title: Randomized, Double Blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children From 0 to 3 Years Old
A prospective case-control multicentric pilot study of 12 weeks duration to evaluate the effect of a probiotic mixture in the treatment of atopic dermatitis in children from 0 to 3 years old, by measuring the severity of the condition using the SCORAD index, as well as the Clinical Global Impression rating scale, the potential decrease in the use of corticosteroids and antihistamines, and the safety of the treatment under study by the number of adverse events related to the product under study.
Read the detailed description
Atopic dermatitis is a chronic inflammatory disease of the skin, which first symptoms usually develop during childhood, and approximately 50% of cases are diagnosed in the first year of life.
The diagnosis of atopic dermatitis is clinical, because there are no specific microscopic or laboratory changes. One aspect of establishing the diagnosis is the measurement of the severity of the process in these patients. In this regard, one of the best validated methods, more contrasted, more accepted, used and most recommended is the composite scale called index SCORAD (Scoring Atopic Dermatitis). This index consists of a scoring system that takes into account the extent and intensity of five fundamental types of lesions (erythema, edema / papule, exudate / scab, excoriation and lichenification), as well as symptoms (pruritus and loss of sleep) they provoke.
The use of probiotics in the treatment of Atopic Dermatitis has been studied in recent years in a limited number of pilot studies with variable results depending on the probiotic used and the age of the patients included in the study. Recent studies, including a meta-analysis of previous publications, demonstrate a beneficial effect of the use of probiotics in certain circumstances related to age, the type of probiotic used, the dose and combination of probiotics.
In our previous study, the efficacy and safety of the probiotic were demonstrated. The objective of this study is to confirm whether the treatment improves the evolution of the SCORAD index (difference between the values of the first visit and the final one) in children under 4 years of age, comparing the mean of this value in the probiotic group with the control group. For this, a similar methodology will be applied and the same mixture of strains will be used as in the previous study.
Generally speaking, the goals of treatment of atopic dermatitis are to prevent itching, remove exudate, cure the infection, remove the inflammatory lesion, and prevent relapses. To eliminate itching, and the scratching caused by it, recently developed antihistamines are usually used from the acute phase, since the classic ones can present adverse effects on the central nervous system (CNS) that interfere with daily activities. In other hand, in the flare fase or acute exacerbation of atopic dermatitis, topical corticosteroids are used daily, and during the remission phase, weekly regimens can be used.
The main and secondary objectives of this study, aimed to asses the effect of a probiotic mixture in atopic dermatitis are :
PRIMARY OBJECTIVE
Determine if the product under study has an effect on the evolution and treatment of atopic dermatitis, defined as a decrease in the SCORAD index score.
SECONDARY OBJECTIVES
Determine whether the product under study causes a decrease in the use of topical corticosteroids.
Study if the product under study has an effect on the evolution of the Clinical Global Impression (CGI).
Check if the treatment under study reduces the need to use antihistamines. Evaluate the rate of compliance with the treatment during the development of the study.
Study the safety of the treatment under study, defined as the number of adverse events related to the product under study, referred by the patient that occur during the development of the study.
- Conditions
- Atopic Dermatitis
- Being tested
- Probiotic mixture with three bacterial strains with maltodextrin as a carrier., Placebo comparator with maltodextrin as a carrier.
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixture with three bacterial strains with maltodextrin as a carrier.Dietary supplement
Sachets containing a probiotic mixture at concentrations equal to or greater than 1x10^9 colony forming unit (CFU) per dose, with maltodextrin as excipient.
Placebo comparator with maltodextrin as a carrier.Other
Sachets containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic mixture Receives: Dietary Supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier. |
| Placebo group | Placebo comparator | Maltodextrine Receives: Other: Placebo comparator with maltodextrin as a carrier. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the SCORAD index at 4,8 and 12 weeks
SCORAD index measures the severity of the disease, wich takes into account the extent and intensity of five types of lesions (erythema, edema/papule, exudate/scab, excoriation and lichenification) as well as subjective symptoms (pruritus and loss of sleep).
Subscales:
Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20
Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
Measured: 12 week
Secondary outcomes (5)
Number of days that each patient requires the administration of topical corticosteroids at 4, 8 and 12 weeks
Measured: 12 week
Number of days that each patient requires the administration of topical corticosteroids in disease flares at 4, 8 and 12 weeks
Measured: 12 week
Change from baseline in the CGI score at 4,8 and 12 weeks
Clinical Global Impression (CGI) measures the severity of the disease on a 6-point scale, based on the global assessment of the skin lesions.
Total: 0 - 5 (Higher values represent a worse outcome)
Measured: 12 week
Number of days that each patient requires the administration of antihistamines at 4, 8 and 12 weeks
Measured: 12 week
Adherence to the treatment at 4, 8 and 12 weeks
Percentage of treatment intake days
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start8 Feb 2023
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Why it stopped: Combination of factors, including operational, logistical and recruitment challenges impacting the timely execution of the study. The termination was not due to any safety concerns related to the investigational product
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionou Research, S.L.
- Sponsor type
- Research network
- Collaborators
- Biopolis S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443490
- Sponsor's protocol ID
- ATOP_PRO.3
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2022
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children From 0 to 3 Years Old
- ClinicalTrials.gov ID
- NCT05443490
- Acronym / sponsor ID
- ATOP_PRO.3
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Combination of factors, including operational, logistical and recruitment challenges impacting the timely execution of the study. The termination was not due to any safety concerns related to the investigational product
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bionou Research, S.L.Research network
- Collaborators
- Biopolis S.L.
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 5 Jul 2022 (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.
A prospective case-control multicentric pilot study of 12 weeks duration to evaluate the effect of a probiotic mixture in the treatment of atopic dermatitis in children from 0 to 3 years old, by measuring the severity of the condition using the SCORAD index, as well as the Clinical Global Impression rating scale, the potential decrease in the use of corticosteroids and antihistamines, and the safety of the treatment under study by the number of adverse events related to the product under study.
Detailed description
Atopic dermatitis is a chronic inflammatory disease of the skin, which first symptoms usually develop during childhood, and approximately 50% of cases are diagnosed in the first year of life.
The diagnosis of atopic dermatitis is clinical, because there are no specific microscopic or laboratory changes. One aspect of establishing the diagnosis is the measurement of the severity of the process in these patients. In this regard, one of the best validated methods, more contrasted, more accepted, used and most recommended is the composite scale called index SCORAD (Scoring Atopic Dermatitis). This index consists of a scoring system that takes into account the extent and intensity of five fundamental types of lesions (erythema, edema / papule, exudate / scab, excoriation and lichenification), as well as symptoms (pruritus and loss of sleep) they provoke.
The use of probiotics in the treatment of Atopic Dermatitis has been studied in recent years in a limited number of pilot studies with variable results depending on the probiotic used and the age of the patients included in the study. Recent studies, including a meta-analysis of previous publications, demonstrate a beneficial effect of the use of probiotics in certain circumstances related to age, the type of probiotic used, the dose and combination of probiotics.
In our previous study, the efficacy and safety of the probiotic were demonstrated. The objective of this study is to confirm whether the treatment improves the evolution of the SCORAD index (difference between the values of the first visit and the final one) in children under 4 years of age, comparing the mean of this value in the probiotic group with the control group. For this, a similar methodology will be applied and the same mixture of strains will be used as in the previous study.
Generally speaking, the goals of treatment of atopic dermatitis are to prevent itching, remove exudate, cure the infection, remove the inflammatory lesion, and prevent relapses. To eliminate itching, and the scratching caused by it, recently developed antihistamines are usually used from the acute phase, since the classic ones can present adverse effects on the central nervous system (CNS) that interfere with daily activities. In other hand, in the flare fase or acute exacerbation of atopic dermatitis, topical corticosteroids are used daily, and during the remission phase, weekly regimens can be used.
The main and secondary objectives of this study, aimed to asses the effect of a probiotic mixture in atopic dermatitis are :
PRIMARY OBJECTIVE
Determine if the product under study has an effect on the evolution and treatment of atopic dermatitis, defined as a decrease in the SCORAD index score.
SECONDARY OBJECTIVES
Determine whether the product under study causes a decrease in the use of topical corticosteroids.
Study if the product under study has an effect on the evolution of the Clinical Global Impression (CGI).
Check if the treatment under study reduces the need to use antihistamines. Evaluate the rate of compliance with the treatment during the development of the study.
Study the safety of the treatment under study, defined as the number of adverse events related to the product under study, referred by the patient that occur during the development of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.Probiotic mixture |
| Placebo group | Placebo comparator | Other: Placebo comparator with maltodextrin as a carrier.Maltodextrine |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Signature of informed consent from the parent / legal guardian of the patient.
- Patients with mild-moderate atopic dermatitis (SCORAD >20).
- Age between 6 months and 3 years old, both inclusive (36 months).
- Patients using topical corticosteroids.
- Diagnosis of atopic dermatitis.
Key exclusion criteria (11 listed)
- In treatment with phototherapy for atopic dermatitis in the previous 2 months
- In treatment with systemic corticosteroids in the previous month.
- In treatment with immunosuppressants or cytostatics in the previous 2 months.
- Those who have received probiotic treatment in the previous month.
- Those who have been treated with systemic antibiotics in the previous two weeks.
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 mixture with three bacterial strains with maltodextrin as a carrier.Sachets containing a probiotic mixture at concentrations equal to or greater than 1x10^9 colony forming unit (CFU) per dose, with maltodextrin as excipient. | Dietary supplement | Probiotic group |
| Placebo comparator with maltodextrin as a carrier.Sachets containing maltodextrin | Other | Placebo group |
Primary outcome
Change from baseline in the SCORAD index at 4,8 and 12 weeks
Time frame: 12 week
SCORAD index measures the severity of the disease, wich takes into account the extent and intensity of five types of lesions (erythema, edema/papule, exudate/scab, excoriation and lichenification) as well as subjective symptoms (pruritus and loss of sleep). Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
5 secondary outcomes
Number of days that each patient requires the administration of topical corticosteroids at 4, 8 and 12 weeks
Time frame: 12 week
Number of days that each patient requires the administration of topical corticosteroids in disease flares at 4, 8 and 12 weeks
Time frame: 12 week
Change from baseline in the CGI score at 4,8 and 12 weeks
Time frame: 12 week
Number of days that each patient requires the administration of antihistamines at 4, 8 and 12 weeks
Time frame: 12 week
Adherence to the treatment at 4, 8 and 12 weeks
Time frame: 12 week
Results and safety
The study was stopped early (reason given: Combination of factors, including operational, logistical and recruitment challenges impacting the timely execution of the study. The termination was not due to any safety concerns related to the investigational product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic mixture with three bacterial strains with maltodextrin as a carrier. in people with Atopic Dermatitis, run by Bionou Research, S.L. at 3 sites in 3 countries.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 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 3 sites in Bolivia, Costa Rica, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Combination of factors, including operational, logistical and recruitment challenges impacting the timely execution of the study. The termination was not due to any safety concerns related to the investigational product). Results are not available in the source record.
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 from baseline in the SCORAD index at 4,8 and 12 weeks (time frame: 12 week). 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 5 May 2026.