A Probiotic That Reduces Atopic Skin

August 10, 2023 updated by: Wecare Probiotics Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • CAP Alhambra of Hospitalet de Llobregat
      • Barcelona, Spain
        • CAP La Mina Carrer Mar Sant Adrià de Besos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Dietary supplement: probiotic LRa05
treatment about 12 weeks
Active Comparator: 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.
Dietary supplement: probiotic LRa05
treatment about 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the outbreaks of atopic skin
Time Frame: 12 weeks
use the SCORAD index to measure the outbreaks of atopic skin
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Collaborators

Methodex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WK2023002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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