Atopic SkinNCT05989295
A Probiotic That Reduces Atopic Skin
A study testing probiotic LRa05 in people with Atopic Skin and Children, run by Wecare Probiotics Co., Ltd. at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Skin, Children
- What is being tested?
- probiotic LRa05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 26 Jan 2022to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
- Patients aged 2-14 years.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
CAP Alhambra of Hospitalet de Llobregat
Barcelona
CAP La Mina Carrer Mar Sant Adrià de Besos
Barcelona
About this study
Official title: 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).
- Conditions
- Atopic Skin, Children
- Being tested
- probiotic LRa05
- Keywords
- atopic skin;, eczema;, child population;, probiotic
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic LRa05Dietary supplement
treatment about 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: probiotic LRa05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the outbreaks of atopic skin
use the SCORAD index to measure the outbreaks of atopic skin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start26 Jan 2022
- Primary completion1 Dec 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic SkinStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Methodex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989295
- Sponsor's protocol ID
- WK2023002
- Status last verified
- Aug 2023
- First submitted
- 17 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin
- ClinicalTrials.gov ID
- NCT05989295
- Acronym / sponsor ID
- WK2023002
- Conditions
- Atopic Skin, Children
- Keywords
- atopic skin;, eczema;, child population;, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Methodex
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: probiotic LRa052.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure. |
| Probiotic group | Active comparator | Dietary Supplement: probiotic LRa05(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. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
- Patients aged 2-14 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic LRa05treatment about 12 weeks | Dietary supplement | Placebo group, Probiotic group |
Primary outcome
the outbreaks of atopic skin
Time frame: 12 weeks
use the SCORAD index to measure the outbreaks of atopic skin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic LRa05 in people with Atopic Skin and Children, run by Wecare Probiotics Co., Ltd. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outbreaks of atopic skin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.