CClinicalTrials.gg
Sign In
CompletedNCT05989295Updated Aug 14, 2023

A Probiotic That Reduces Atopic Skin

An interventional study of probiotic LRa05 in Atopic Skin and Children, sponsored by Wecare Probiotics Co., Ltd.. Completed at 2 sites in Spain. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Atopic Skin
  • Children

Keywords

  • atopic skin;
  • eczema;
  • child population;
  • probiotic
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementprobiotic LRa05

    treatment about 12 weeks

06

What researchers measure

Primary outcomes

  1. the outbreaks of atopic skin

    use the SCORAD index to measure the outbreaks of atopic skin

    Time frame: 12 weeks

07

Study locations

2 sites
  • CAP Alhambra of Hospitalet de Llobregat
    Barcelona, Spain
  • CAP La Mina Carrer Mar Sant Adrià de Besos
    Barcelona, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05989295
Lead sponsor
Wecare Probiotics Co., Ltd.
Collaborators
Methodex
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jan 26, 2022
Primary completion
Dec 1, 2022
Completion
Apr 21, 2023
Last update
Aug 14, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Wecare Probiotics Co., Ltd.

Start the discussion