A Probiotic That Reduces Atopic Skin

The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05989295

Enrollment

Registered

2023-08-14

Start date

2022-01-26

Completion date

2023-04-21

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Skin, Children

Keywords

atopic skin;, eczema;, child population;, probiotic

Brief summary

To assess the efficacy and safety of the use of probiotics as food supplements in reducing the SCORAD index in children with atopic skin compared with placebo. This is a randomized, placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. Patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05) and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).

Interventions

DIETARY_SUPPLEMENTprobiotic LRa05

treatment about 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

1. Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40). 2. Patients aged 2-14 years.

Exclusion criteria

* Patients intolerant to gluten, lactose or cow's milk protein. * Patients who change the type of diet during the study to improve their atopic dermatitis. * Patients with atopic dermatitis in remission phase (absence of sprouts and with SCORAD index = 0). * Patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study. * Patients taking immunomodulators, topical or oral antibiotics, topical or oral antihistamines, oral corticosteroids or antineoplastics. * Subjects whose condition does not make them eligible for the study, according to the investigator.

Design outcomes

Primary

Measure	Time frame	Description
the outbreaks of atopic skin	12 weeks	use the SCORAD index to measure the outbreaks of atopic skin

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026