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Can a probiotic soothe Children's eczema?

NCT ID NCT03863418

Disease control Sponsor: Federico II University 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether the probiotic Lactobacillus rhamnosus GG can ease atopic dermatitis, a chronic skin condition causing dry, itchy patches, in children aged 6 to 36 months. Half of the 100 participants receive the probiotic daily, while the other half get a placebo. Researchers measure changes in a standard eczema severity score and also look at gut bacteria and immune markers. The goal is to see if this supplement offers a safe, additional way to manage eczema symptoms.

What this could mean

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

Active substance
Lactobacillus rhamnosus GG, a probiotic supplement
What this could lead to
If it works, this could point toward a simple, safe supplement to help manage eczema symptoms in young children.
What could go wrong
This is an early-stage trial with 100 children, and previous studies on probiotics for eczema have shown mixed results. The supplement may not improve symptoms, and individual responses can vary.

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

100 people

The number who actually took part.

Started

May 2019

Finished

Dec 2020

Lead sponsor

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

6 to 36 months

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: * Children aged 6-36 months * diagnosis of Atopic Dermatitis according to SCORAD index Exclusion Criteria * Age \< 6 months * age \> 36 months, * skin infections, * ichthyosis, * food allergies, * other allergic diseases, * chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal and/or respiratory tract, * administration of prebiotics/ probiotics/symbiotic/systemic immunomodulators during the 4 weeks before enrolment, * treatments with topical immunomodulators (Tacrolimus or Pimecrolimus) over the three months prior to enrolment; * use of corticosteroids or calcineurin antagonists or phototherapy in the previous 4 weeks, * use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry; * investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study; * hypersensitivity to components contained in study product.

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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

  • University of Naples Federico II

    Naples, Naples, 80131, Italy

More trials for these conditions

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