Probiotics Regulates Skin Care in Children
1 other identifier
interventional
148
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2021
CompletedFirst Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 19, 2023
July 1, 2023
3.2 years
August 10, 2021
July 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Skin severity scoring
According to the scale to estimate skin severity
3 months
Secondary Outcomes (3)
Blood analysis
3 months
NGS in gastrointestinal tract
3 months
Life quality
3 months
Study Arms (4)
Placebo
PLACEBO COMPARATORProbiotics Lactobacillus salivarius AP-32
EXPERIMENTALProbiotics Bifidobacterium animalis subsp. lactis CP-9
EXPERIMENTALProbiotics Lactobacillus rhamnosus LGG
EXPERIMENTALInterventions
A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day
A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day
A pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day
Eligibility Criteria
You may qualify if:
- Estimated by PI.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Memorial Hospitallead
- Glac Biotech Co., Ltdcollaborator
Study Sites (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 13, 2021
Study Start
May 31, 2021
Primary Completion
July 31, 2024
Study Completion
December 31, 2024
Last Updated
July 19, 2023
Record last verified: 2023-07