Children Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Glac Biotech Co., Ltd. | Tainan City |
Lead Sponsor | Collaborator |
---|---|
Glac Biotech Co., Ltd |
Taiwan,
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT02553486 -
Internationally Adopted Children Quality of Life
|
N/A | |
Completed |
NCT02903134 -
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
|
||
Completed |
NCT02918890 -
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
|
N/A | |
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Enrolling by invitation |
NCT01971827 -
Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
|
N/A | |
Enrolling by invitation |
NCT01971840 -
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
|
N/A | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Completed |
NCT01943760 -
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
|
Phase 4 | |
Completed |
NCT01693926 -
Effect of Physical Activity an Stress in Children
|
N/A | |
Completed |
NCT01864811 -
Effect of Baby-CIMT in Infants Younger Than 12 Months
|
N/A | |
Completed |
NCT01323010 -
Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes
|
N/A | |
Completed |
NCT01277224 -
Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren
|
N/A | |
Active, not recruiting |
NCT00989547 -
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
|
Phase 1 | |
Completed |
NCT04051723 -
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
|
Phase 4 | |
Completed |
NCT03236337 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
|
N/A | |
Completed |
NCT03236363 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
|
N/A | |
Not yet recruiting |
NCT03427697 -
Effect of VR and Accommdation Relax on Controlling Myopia in Children
|
N/A | |
Completed |
NCT05603507 -
Inspiratory Muscle Training in Children With Chest Burn
|
N/A | |
Not yet recruiting |
NCT06267339 -
Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
|
Early Phase 1 |