UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052518 |
|---|---|
| Receipt number | R000059934 |
| Scientific Title | Levilactobacillus brevis KB290 intake on bowel movement and intestinal environment: an updated systematic review with meta-analysis |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2023/10/17 16:47:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Levilactobacillus brevis KB290 on bowel movement and intestinal environment: a systematic review.
Acronym
Effect of Levilactobacillus brevis KB290 on bowel movement and intestinal environment: a systematic review.
Scientific Title
Levilactobacillus brevis KB290 intake on bowel movement and intestinal environment: an updated systematic review with meta-analysis
Scientific Title:Acronym
Levilactobacillus brevis KB290 intake on bowel movement and intestinal environment: a systematic review
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of dietary intake of Levilactobacillus brevis KB290 on bowel movement and intestinal environment in healthy adults.
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 bowel movement frequency.
Key secondary outcomes
We will evaluate of the effects of Levilactobacillus brevis KB290 intake on the number of Lactobacillus group and Bifidobacterium genus in stool sample, concentration of organic acids (total organic acid, acetic acid, propionic acid) in stool sample, and feeling after defecation.
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
(PICOS)
Participant:
Healthy adults without illness (excluding pregnant women [including those planning to become pregnant] and lactating women)
Intervention:
Oral intake of test food containing Levilactobacillus brevis KB290 (regardless of the form and amount of intake)
Comparison:
Oral intake of test food without Levilactobacillus brevis KB290, or no intervention
Outcome measurement:
Bowel movement frequency as primary outcome.
The number of Lactobacillus group and Bifidobacterium genus in stool sample, concentration of organic acids (total organic acid, acetic acid, propionic acid) in stool sample, and feeling after defecation as secondary outcomes.
Study design:
Randomized controlled parallel trials (RCT-P), randomized controlled crossover trials (RCT-C), quasi-randomized controlled parallel trials (qRCT-P), quasirandomized controlled crossover trials (qRCT-C), non-randomized controlled parallel trials (nonRCT-P), non-randomized controlled crossover trials (nonRCT-C), and non-randomized controlled trials
(Language)
Eligibility is not restricted by language.
Key exclusion criteria
Exclude proceedings and unpublished studies which don't give us enough research details, and other gray documents that are difficult to verify.
Target sample size
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 | Chinatsu |
| Middle name | |
| Last name | Arakawa |
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
None
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
Kagome Ethics Committee
Address
Nihonbashi-Hamacho F Tower 3-21-1, Nihonbashi-Hamacho, Chuo-ku, Tokyo
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
| 2025 | Year | 04 | Month | 01 | 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
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | 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)
Research papers will be searched for 4 databases. To increase the comprehensiveness, the studies whose existence has been revealed by hand search, requotation, or other methods will be added to the review.
(Selection and data collection process)
Screening and data extraction based on eligibility criteria (PICOS) will be conducted independently by two reviewers.
(Risk of bias assessment and indirectness evaluation)
Assessment of the quality and evaluation of the indirectness of articles will be conducted independently by two reviewers. A full quality appraisal of these papers will be made using modified check list (13 items) of Cochrane Handbook for interventional trials. The agreement rate and the kappa coefficient will be calculated to determine the degree of agreement. Studies evaluated as having a high risk of bias will not be adopted.
(Data synthesis)
A meta-analysis will be performed using RevMan only in 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. Sensitivity analysis and subgroup analysis will be performed as necessary.
(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.
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059934
