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Eczema probiotic trial for kids ends early – too few participants

NCT ID NCT05443490

Disease control Sponsor: Bionou Research, S.L. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a probiotic supplement for children aged 6 months to 3 years with mild-to-moderate eczema. The goal was to see if the probiotic could reduce eczema severity and the need for steroid creams. However, the trial was terminated early and only enrolled 4 children, so no meaningful conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
probiotic mixture (three bacterial strains)
What this could lead to
If it worked, this could point toward a probiotic supplement to help manage eczema in young children.
What could go wrong
The trial was terminated early with only 4 participants, so we cannot draw any reliable conclusions. Probiotics may not affect eczema severity.

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

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

4 people

The number who actually took part.

Started

Feb 2023

Finished

Jun 2023

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 3 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Centro de Especialidades Dermatológicas Ac S.A (Dermaláser)

    San José, Provincia de San José, Sabana Oeste, T. Médica 20/20, Costa Rica

  • Hospital Universitario del Vinalopó

    Elche, Alicante, 03293, Spain

  • Hospital del niño Dr. Ovidio Aliaga Uria y Hospital Arco Iris

    La Paz, La Paz Department, 10097, Bolivia

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