Probiotics Regulates Skin Care in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Children; Probiotics; Skin Care
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotics Lactobacillus salivarius AP-32; Dietary supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9; Dietary supplement: Probiotics Lactobacillus rhamnosus LGG

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuo Ho-Chang; Phone Number: 8320 (07)7317123; Email: erickuo48@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Ho-Chang Kuo, MD, PhD; Phone Number: 8320 +886-7-7317123; Email: erickuo48@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; A pack of powder without probiotics. 1 pack / day
Experimental: Probiotics Lactobacillus salivarius AP-32	Dietary supplement: Probiotics Lactobacillus salivarius AP-32; A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day
Experimental: Probiotics Bifidobacterium animalis subsp. lactis CP-9	Dietary supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9; A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day
Experimental: Probiotics Lactobacillus rhamnosus LGG	Dietary supplement: Probiotics Lactobacillus rhamnosus LGG; A pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin severity scoring	According to the scale to estimate skin severity	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood analysis	ELISA analysis	3 months
NGS in gastrointestinal tract	The difference of NGS ( Next Generation Sequence ) in gastrointestinal tract between 0 month and the 3rd month.	3 months
Life quality	The questionnaire of life quality in three months.	3 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Glac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: XPRPG8L0021~22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No