A Probiotic That Reduces Atopic Skin

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05989295
• Other study ID #: WK2023002
• Status: Completed
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: April 21, 2023

Study information

• Verified date: August 2023
• Source: Wecare Probiotics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 21, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children

Intervention

Dietary Supplement:
• probiotic LRa05
treatment about 12 weeks

Locations

Country	Name	City	State
Spain	CAP Alhambra of Hospitalet de Llobregat	Barcelona
Spain	CAP La Mina Carrer Mar Sant Adrià de Besos	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.	Methodex

Country where clinical trial is conducted

Spain, 

Outcome

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