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Completed

NCT Number: NCT05989295

A Probiotic That Reduces Atopic Skin

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).

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Key information

Conditions

Atopic Skin Children Dermatitis Eczema Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Alhambra of Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
  • 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.

Treatment and study plan

probiotic LRa05

Dietary Supplement

treatment about 12 weeks

Primary outcomes

  1. the outbreaks of atopic skin

    Time frame: 12 weeks

    use the SCORAD index to measure the outbreaks of atopic skin

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Collaborators

  • Methodex

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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