A Probiotic That Reduces Atopic Skin

Sponsor

Wecare Probiotics Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05989295

Collaborator

Methodex (Other)

Enrollment

Locations

Arms

14.8

Actual Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atopic Skin Children	Dietary Supplement: probiotic LRa05	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 26, 2022

Actual Primary Completion Date :

Dec 1, 2022

Actual Study Completion Date :

Apr 21, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the outbreaks of atopic skin [12 weeks]
use the SCORAD index to measure the outbreaks of atopic skin

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAP Alhambra of Hospitalet de Llobregat	Barcelona		Spain
2	CAP La Mina Carrer Mar Sant Adrià de Besos	Barcelona		Spain

Sponsors and Collaborators

Wecare Probiotics Co., Ltd.
Methodex

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wecare Probiotics Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05989295

Other Study ID Numbers:

WK2023002

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wecare Probiotics Co., Ltd.

Study Results

No Results Posted as of Aug 14, 2023