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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337670
Other study ID # KCGMHCTC-2019001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
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.


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.

Study Design


Related Conditions & MeSH terms


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.
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