A Probiotic That Reduces Atopic Skin

NCT05989295 | Completed

• 1 other identifier: WK2023002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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).

Conditions

Atopic Skin; Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the outbreaks of atopic skin

  use the SCORAD index to measure the outbreaks of atopic skin

  12 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

2.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.

Dietary Supplement: probiotic LRa05

Probiotic group

ACTIVE COMPARATOR

(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.

Dietary Supplement: probiotic LRa05

Interventions

probiotic LRa05 DIETARY_SUPPLEMENT

treatment about 12 weeks

Placebo group; Probiotic group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead
• Methodex: collaborator

Study Sites (2)

CAP Alhambra of Hospitalet de Llobregat

Barcelona, Spain

Location

CAP La Mina Carrer Mar Sant Adrià de Besos

Barcelona, Spain

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 14, 2023
• Study Start: January 26, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 21, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)