A Probiotic That Reduces Atopic Skin

NCT ID: NCT05989295

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2023-04-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

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

Group Type: PLACEBO_COMPARATOR

probiotic LRa05

Intervention Type: DIETARY_SUPPLEMENT

treatment about 12 weeks

Probiotic group

(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.

Group Type: ACTIVE_COMPARATOR

probiotic LRa05

Intervention Type: DIETARY_SUPPLEMENT

treatment about 12 weeks

Interventions

probiotic LRa05

treatment about 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Methodex

INDUSTRY

Sponsor Role: collaborator

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CAP Alhambra of Hospitalet de Llobregat

Barcelona, , Spain

CAP La Mina Carrer Mar Sant Adrià de Besos

Barcelona, , Spain

Countries

Spain

Other Identifiers

WK2023002

Identifier Type: -

Identifier Source: org_study_id