Skin CareNCT05005611
Probiotics Regulates Skin Care in Children
A study testing Probiotics Lactobacillus salivarius AP-32, Probiotics Bifidobacterium animalis subsp. lactis CP-9 and Probiotics Lactobacillus rhamnosus LGG in people with Skin Care and Probiotics, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Skin Care, Probiotics, Children
- What is being tested?
- Probiotics Lactobacillus salivarius AP-32, Probiotics Bifidobacterium animalis subsp. lactis CP-9 and Probiotics Lactobacillus rhamnosus LGG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2021to 31 Dec 2024
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated by PI.
Who cannot join
- Be allergic to medicine
- Take medicine like immune inhibition, or steroid injection in two weeks
- Participate in another clinical research or immune therapy in one month
- Have severe disease
- Inappropriate for this trial judged by PI
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Ho-Chang Kuo, MD, PhD, +886-7-7317123 ext. 8320, erickuo48@yahoo.com.tw
About this study
Official title: Probiotics Regulates Skin Care in Children : A Randomized, Double-blind Clinical Trial With Placebo
Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not.
- Conditions
- Skin Care, Probiotics, Children
- Being tested
- Placebo, Probiotics Lactobacillus salivarius AP-32, Probiotics Bifidobacterium animalis subsp. lactis CP-9, Probiotics Lactobacillus rhamnosus LGG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
A pack of powder without probiotics.
1 pack / day
Probiotics Lactobacillus salivarius AP-32Dietary supplement
A pack of powder with probiotics Lactobacillus salivarius AP-32
1 pack / day
Probiotics Bifidobacterium animalis subsp. lactis CP-9Dietary supplement
A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9
1 pack / day
Probiotics Lactobacillus rhamnosus LGGDietary supplement
A pack of powder with probiotics Lactobacillus rhamnosus LGG
1 pack / day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Probiotics Lactobacillus salivarius AP-32 | Experimental | Not described Receives: Dietary Supplement: Probiotics Lactobacillus salivarius AP-32 |
| Probiotics Bifidobacterium animalis subsp. lactis CP-9 | Experimental | Not described Receives: Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9 |
| Probiotics Lactobacillus rhamnosus LGG | Experimental | Not described Receives: Dietary Supplement: Probiotics Lactobacillus rhamnosus LGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin severity scoring
According to the scale to estimate skin severity
Measured: 3 months
Secondary outcomes (3)
Blood analysis
ELISA analysis
Measured: 3 months
NGS in gastrointestinal tract
The difference of NGS ( Next Generation Sequence ) in gastrointestinal tract between 0 month and the 3rd month.
Measured: 3 months
Life quality
The questionnaire of life quality in three months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start31 May 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Skin Care in children.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glac Biotech Co., Ltd
- Responsible party
- Principal investigator, Ho-Chang Kuo, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005611
- Sponsor's protocol ID
- XPRPG8L0021~22
- Status last verified
- Jul 2023
- First submitted
- 10 Aug 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Regulates Skin Care in Children : A Randomized, Double-blind Clinical Trial With Placebo
- ClinicalTrials.gov ID
- NCT05005611
- Acronym / sponsor ID
- XPRPG8L0021~22
- Conditions
- Skin Care, Probiotics, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Glac Biotech Co., Ltd
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Aug 2021 (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.
Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Skin Care in children.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Probiotics Lactobacillus salivarius AP-32 | Experimental | Dietary Supplement: Probiotics Lactobacillus salivarius AP-32 |
| Probiotics Bifidobacterium animalis subsp. lactis CP-9 | Experimental | Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9 |
| Probiotics Lactobacillus rhamnosus LGG | Experimental | Dietary Supplement: Probiotics Lactobacillus rhamnosus LGG |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Estimated by PI.
Key exclusion criteria (5 listed)
- Be allergic to medicine
- Take medicine like immune inhibition, or steroid injection in two weeks
- Participate in another clinical research or immune therapy in one month
- Have severe disease
- Inappropriate for this trial judged by PI
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 |
|---|---|---|
| PlaceboA pack of powder without probiotics. 1 pack / day | Dietary supplement | Placebo |
| Probiotics Lactobacillus salivarius AP-32A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day | Dietary supplement | Probiotics Lactobacillus salivarius AP-32 |
| Probiotics Bifidobacterium animalis subsp. lactis CP-9A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day | Dietary supplement | Probiotics Bifidobacterium animalis subsp. lactis CP-9 |
| Probiotics Lactobacillus rhamnosus LGGA pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day | Dietary supplement | Probiotics Lactobacillus rhamnosus LGG |
Primary outcome
Skin severity scoring
Time frame: 3 months
According to the scale to estimate skin severity
3 secondary outcomes
Blood analysis
Time frame: 3 months
NGS in gastrointestinal tract
Time frame: 3 months
Life quality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics Lactobacillus salivarius AP-32, Probiotics Bifidobacterium animalis subsp. lactis CP-9 and Probiotics Lactobacillus rhamnosus LGG in people with Skin Care and Probiotics, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo Ho-Chang ((07)7317123 ext. 8320, erickuo48@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin severity scoring (time frame: 3 months). 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 19 Jul 2023.