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RecruitingNCT05005611Updated Jul 19, 2023

Probiotics Regulates Skin Care in Children

An interventional study of Placebo and Probiotics Lactobacillus salivarius AP-32 in Skin Care, Probiotics and Children, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Care
  • Probiotics
  • Children
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

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

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Estimated by PI.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
148 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

  • Experimental
    Probiotics Lactobacillus salivarius AP-32

    Dietary Supplement: Probiotics Lactobacillus salivarius AP-32

  • Experimental
    Probiotics Bifidobacterium animalis subsp. lactis CP-9

    Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9

  • Experimental
    Probiotics Lactobacillus rhamnosus LGG

    Dietary Supplement: Probiotics Lactobacillus rhamnosus LGG

Interventions

  • Dietary supplementPlacebo

    A pack of powder without probiotics. 1 pack / day

  • Dietary supplementProbiotics Lactobacillus salivarius AP-32

    A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day

  • Dietary supplementProbiotics Bifidobacterium animalis subsp. lactis CP-9

    A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day

  • Dietary supplementProbiotics Lactobacillus rhamnosus LGG

    A pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day

06

What researchers measure

Primary outcomes

  1. Skin severity scoring

    According to the scale to estimate skin severity

    Time frame: 3 months

Secondary outcomes

  1. Blood analysis

    ELISA analysis

    Time frame: 3 months

  2. NGS in gastrointestinal tract

    The difference of NGS ( Next Generation Sequence ) in gastrointestinal tract between 0 month and the 3rd month.

    Time frame: 3 months

  3. Life quality

    The questionnaire of life quality in three months.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung City, 83301, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05005611
Lead sponsor
Chang Gung Memorial Hospital
Collaborators
Glac Biotech Co., Ltd
Responsible party
Ho-Chang Kuo (Attending Physician, Chang Gung Memorial Hospital) — Principal investigator
First posted
Aug 13, 2021
Start date
May 31, 2021
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 19, 2023

Study contacts

Kuo Ho-Chang
Contact
erickuo48@yahoo.com.tw
(07)7317123 ext. 8320

Oversight

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

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