An interventional study of Probiotic mixture with three bacterial strains with maltodextrin as a carrier. and Placebo comparator with maltodextrin as a carrier. in Atopic Dermatitis, sponsored by Bionou Research, S.L.. Terminated at 3 sites in 3 countries. Open to participants aged 6 Months to 3 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Bionou Research, S.L. · Not applicable, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 4 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Bionou Research, S.L. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic mixture
Dietary Supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
Maltodextrine
Other: Placebo comparator 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.
Sachets containing maltodextrin
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)
Time frame: 12 week
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
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)
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
Percentage of treatment intake days
Time frame: 12 week
Number of adverse events from baseline at weeks 4, 8 and 12
Adverse events referred by the patient's parents that occur during the development of the study
Time frame: 12 week
Plan to share: No
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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Bionou Research, S.L.