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NCT05005611 Clinical Trial

Probiotics Regulates Skin Care in Children

Children Clinical Trial

Official title:
Probiotics Regulates Skin Care in Children : A Randomized, Double-blind Clinical Trial With Placebo

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05005611
Other study ID # XPRPG8L0021~22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2021
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source Chang Gung Memorial Hospital
Contact Kuo Ho-Chang
Phone (07)7317123
Email erickuo48@yahoo.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Other known NCT identifiers
  • NCT05337670

Recruitment information / eligibility
Status Recruiting
Enrollment 148
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria: - Estimated by PI. 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Placebo
A pack of powder without probiotics. 1 pack / day
• Probiotics Lactobacillus salivarius AP-32
A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day
• Probiotics Bifidobacterium animalis subsp. lactis CP-9
A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day
• Probiotics Lactobacillus rhamnosus LGG
A pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung City

Sponsors (2)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital Glac Biotech Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin severity scoring According to the scale to estimate skin severity 3 months
Secondary Blood analysis ELISA analysis 3 months
Secondary NGS in gastrointestinal tract The difference of NGS ( Next Generation Sequence ) in gastrointestinal tract between 0 month and the 3rd month. 3 months
Secondary Life quality The questionnaire of life quality in three months. 3 months
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