Probiotics Regulates Skin Care in Children

Study Overview
=================
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.

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

Conditions
-----------------
Skin Care, Probiotics, Children

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Skin Care in children.
Masking: Double


Arms and Interventions

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

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 |