UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055534 |
|---|---|
| Receipt number | R000063466 |
| Scientific Title | The skin moisturizing effect of Levilactobacillus brevis KB290: a systematic review with meta-analysis |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/18 16:45:44 |
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Basic information
Public title
The skin moisturizing effect of Levilactobacillus brevis KB290: a systematic review with meta-analysis
Acronym
The skin moisturizing effect of Levilactobacillus brevis KB290.
Scientific Title
The skin moisturizing effect of Levilactobacillus brevis KB290: a systematic review with meta-analysis
Scientific Title:Acronym
The skin moisturizing effect of Levilactobacillus brevis KB290.
Region
| Japan |
Condition
Condition
We will include healthy people not suffering from any diseases. We will exclude minors (less than 18 years old, pregnant women, those planning a pregnancy, and lactating women).
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the skin moisturizing effect of Levilactobacillus brevis KB290.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We will evaluate the effect of Levilactobacillus brevis KB290 intake on levels of water content in stratum corneum.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(Study design)
We will include randomized controlled parallel trials (RCT-P), randomized controlled crossover trials (RCT-C), quasi-randomized controlled parallel trials (qRCT-P), quasi-randomized controlled crossover trials (qRCT-C), non-randomized controlled parallel trials (nonRCT-P), non-randomized controlled crossover trials (nonRCT-C), and non-randomized controlled trials.We will include scientific papers and reports which give us enough research details.
(PICO)
Participant:
We will include healthy people not suffering from any diseases. We will exclude minors (less than 18 years old, pregnant women, those planning a pregnancy, and lactating women).
Intervention:
We define oral intake of Levilactobacillus brevis KB290 as an intervention (regardless of the form and amount of intake).
Comparison:
We define oral intake of test food not containing Levilactobacillus brevis KB290 or no intake of test food as controls.
Outcome measurement:
We will evaluate levels of water content in stratum corneum as primary outcome.
(Language)
Eligibility is not restricted by language.
Key exclusion criteria
We will exclude proceedings and unpublished studies which do not give us enough research details.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO.,LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
g167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Satomi |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
g167_0@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD. (Self funding)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Review Committee of KAGOME CO., LTD.
Address
Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo 103-8461, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search strategy: Six databases will be used for the search in this study. We will search from the beginning of each database to the search date.
Selection and data collection process: Screening and data extraction based on eligibility criteria will be conducted. Disagreements and uncertainties will be resolved by discussion between the reviewers.
Risk of bias assessment and indirectness evaluation: A full quality appraisal of these papers will be made using modified check list of Cochrane Handbook for interventional trials. Disagreements and uncertainties will be resolved by discussion between the reviewers. Studies evaluated as having a high risk of bias will not be adopted.
Data synthesis: A meta-analysis will be performed using RevMan after the reviewers confirm the absence of heterogeneity. Studies with missing or uncertain data will be excluded if no data is available by contacting the author. If not suitable for integration, a qualitative assessment will be carried out. Estimated heterogeneity and publication bias will be assessed from I square value in Forest plot and Funnel plot, respectively.
Imprecision assessment: Imprecision will be assessed based on the total number of participants in all included studies.
Inconsistency evaluation: Inconsistency will be evaluated by the I square value and statistical test for heterogeneity in a meta-analysis. If a meta-analysis cannot be performed, it will be assessed from the percentage of studies that have had a significant effect.
Publication bias: It will be assessed from Funnel plot in a meta-analysis. If a meta-analysis cannot be performed, it will be assessed from the reporting status of studies registered in research registries.
Sensitivity analyses and sub-group analyses: These analyses will be conducted according to the following items: the analysis excluding studies with extremely large sample sizes, the analysis limited to RCTs, and the analysis divided by measurement sites.
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063466
