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: NCT05337670
• Other study ID #: KCGMHCTC-2019001
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: April 2022
• Source: Glac Biotech Co., Ltd
• Contact: Yi-Wei Kuo
• Phone: 886-6-5891871
• Email: vic.kuo[@]bioflag.com.tw
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: October 15, 2022
• Est. primary completion date: July 15, 2022
• 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.

Related Conditions & MeSH terms

• Children
• Probiotics
• Skin Care

Intervention

Dietary Supplement:
• Placebo
A pack of powder without probiotics. 1 pack / day.
• Lactobacillus salivarius subsp. salicinius
A pack of powder with Lactobacillus salivarius subsp. salicinius. 1 pack / day.
• Bifidobacterium animalis subsp. lactis
A pack of powder with Bifidobacterium animalis subsp. lactis. 1 pack / day.
• Lactobacillus rhamnosus
A pack of powder with Lactobacillus rhamnosus. 1 pack / day.

Locations

Country	Name	City	State
Taiwan	Glac Biotech Co., Ltd.	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
Glac Biotech Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in scoring atopic dermatitis (SCORAD) scores.	Changes in scoring atopic dermatitis (SCORAD) scores were assessed before and 3 months of intervention. The minimum value is "0" and maximum value is "103", higher scores mean a worse outcome.	Before and 3 months of intervention.
Secondary	Changes in immune Index (pg/mL).	Changes in IFN-?, IL-4, IL-10, IL-12, IL-13, TNF-a, TGF-ß (pg/mL) were assessed by ELISA before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in immune index (ng/mL).	Changes in IgE and ECP (ng/mL) were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in WBC cell count.	Changes in WBC cell count were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in class of MAST.	Changes in class of MAST were assessed before and 3 months of intervention. There are 5 classes of MAST, (Class 0): < 26 (LU), (Class 1): 26~65 (LU), (Class 2): 66~142 (LU), (Class 3): 143~242 (LU) and (Class 4): > 242 (LU).	Before and 3 months of intervention.
Secondary	Changes in IgG4 concentration (mg/dL).	Changes in IgG4 (mg/dL) were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in liver function index (GOT, GPT, ?-glutamyltransferase and alkaline phosphatase).	Changes in GOT, GPT, ?-glutamyltransferase and alkaline phosphatase were assessed before and 3 months of intervention. The unit of these 4 indicators is U/L.	Before and 3 months of intervention.
Secondary	Changes in eGFR.	Changes in eGFR (mL/min/1.73m^2) were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in renal function index (BUN, creatinine and uric acid).	Changes in BUN, creatinine and uric acid (mg/dL) were assessed before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in gut microbiota ratios.	Changes in gut microbiota ratios were assessed by next generation sequencing (NGS) before and 3 months of intervention.	Before and 3 months of intervention.
Secondary	Changes in infants' dermatitis quality of life (IDQOL) index.	Changes in infants' dermatitis quality of life (IDQOL) index were assessed by questionnaire before and 3 months of intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.	Before and 3 months of intervention.
Secondary	Changes in children's dermatology life quality index (CDLQI) scores.	Changes in children's dermatology life quality index (CDLQI) scores were assessed by questionnaire before and 3 months of intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.	Before and 3 months of intervention.
Secondary	Changes in dermatitis family impact (DFI) scores.	Changes in dermatitis family impact (DFI) scores were assessed by questionnaire before and 3 months of intervention. The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.	Before and 3 months of intervention.
Secondary	Changes in subjects' frequency of medicine use from questionnaires.	Changes in subjects' frequency of medicine use were assessed from questionnaire before and 3 months of intervention. When subjects returned to the clinic, the average daily medicine use over the past month is asked by a professional physician.	Before and 3 months of intervention.