A Probiotic That Reduces Atopic Skin

Not Applicable

Completed

• Conditions: Atopic Skin; Children
• Interventions: Dietary Supplement: probiotic LRa05

• Registration Number: NCT05989295
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-26
• Primary Completion: 2022-12-01
• Study Completion: 2023-04-21
• Study First Submitted: 2023-07-17
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	probiotic LRa05	2.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.
Probiotic group	probiotic LRa05	(2B CFU/sachet) Lactobacillus rhamnosus LRa05 and maltodextrin Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.

Primary Outcome Measures

Name	Time	Method
the outbreaks of atopic skin	12 weeks	use the SCORAD index to measure the outbreaks of atopic skin

Trial Locations

Locations (2)

CAP La Mina Carrer Mar Sant Adrià de Besos; 🇪🇸 Barcelona, Spain

CAP Alhambra of Hospitalet de Llobregat; 🇪🇸 Barcelona, Spain