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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029963
Receipt No. R000034227
Scientific Title Effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment: a systematic review with meta-analysis
Date of disclosure of the study information 2018/12/31
Last modified on 2019/07/29

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Basic information
Public title Effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment: a systematic review with meta-analysis
Acronym Effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment
Scientific Title Effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment: a systematic review with meta-analysis
Scientific Title:Acronym Effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment
Region
Japan

Condition
Condition This study will be restricted to all original articles of healthy adults (people not suffering from any diseases). We will exclude minors, 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 assess effects of Lactobacillus brevis KB290 intake on bowel movement and intestinal environment.
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 Lactobacillus brevis KB290 intake on bowel movement frequency.
Key secondary outcomes We will evaluate of the effects of Lactobacillus 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (Study design)
We will include randomized controlled trials (RCT), quasi randomized controlled trials (qRCT), non-randomized controlled trials (nonRCT), crossover trials, cohort studies, and case-control studies.
We will include scientific papers and reports which give us enough research details.

(PICO)
Participant:
We will include people not suffering from any diseases. We will exclude minors, pregnant women, those planning a pregnancy, and lactating women.

Intervention:
We define oral intake of Lactobacillus brevis KB290 as an intervention.

Comparison:
We define oral intake of test food not containing Lactobacillus brevis KB290 or maintaining daily life as controls.

Outcome measurement:
We will evaluate bowel movement frequency as primary outcome.
We will evaluate 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.

(PECO)
Participant:
We will include people not suffering from any diseases. We will exclude minors, pregnant women, those planning a pregnancy, and lactating women.

Exposure:
We define oral intake of Lactobacillus brevis KB290 as an exposure.

Comparison:
We define eating no food containing Lactobacillus brevis KB290 as non-exposure. If subgroup analysis of Lactobacillus brevis KB290 intake amount has been conducted in a study, we define the least intake group as a non-exposure group.

Outcome measurement:
We will evaluate bowel movement frequency as primary outcome.
We will evaluate 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.

(Language)
Eligibility is not restricted by language.
Key exclusion criteria We will exclude cross-sectional studies because it will be difficult to interpret causal relationships between exposure and outcome. We will also exclude proceedings and unpublished studies which don't give us enough research details.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Aizawa
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Aizawa
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL 0287-36-2935
Homepage URL
Email Koichi_Aizawa@kagome.co.jp

Sponsor
Institute KAGOME CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Review Team
Mr. Takuro Inoue, Innovation Division,
KAGOME CO., LTD.
Mr. Kazutaka Yoshida, Innovation Division, KAGOME CO., LTD.
Mr. Yudai Aoki, Innovation Division, KAGOME CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address Nihonbashi-Hamacyo F Tower 3-21-1, Nihonbashi-Hmacyo, Chuo-ku, Tokyo
Tel 03-5623-8501
Email 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
2018 Year 12 Month 31 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 Main results already published
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
2017 Year 11 Month 14 Day
Anticipated trial start date
2017 Year 11 Month 15 Day
Last follow-up date
2018 Year 06 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (Searches)
Two authors (e.g., KY and YA) will search 4 databases for studies from the beginning of each database to the search date.

(Data extraction)
Two authors (e.g., KY and YA) will independently apply all criteria to the full text of articles that have passed the first eligibility screening. Then they will independently extract data from the included studies and cross-check the data.

(Risk of bias assessment)
In order to ensure that variation is not caused by systematic errors in the study or execution, two authors (e.g., KY and YA) will independently assess the quality of articles. A full quality appraisal of these papers will be made using modified check list (12 items) of Cochrane Handbook for interventional trials, or modified check list (5 items) of GRADE Handbook for observational trials. We will exclude papers with high risk of bias.

Disagreement and uncertainties will be resolved by discussion with another author (e.g., TI). In addition, we will calculate agreement rate and kappa coefficient.

(Inconsistency evaluation)
We will evaluate inconsistency of evidence according to the value of I square and by a statistical test for heterogeneity of effect estimates in a meta-analysis.

(Imprecision assessment)
We will assess imprecision based on the total number of participants in all included studies.

(Meta-analysis)
Only when we will not find heterogeneity in RCT, qRCT, nonRCT, and crossover trials, TI will conduct a meta-analysis. If we will find missing data, we will make contact with the author to obtain the data.
We will assess heterogeneity according to the value of I square in Forest plot and assess publication bias using Funnel plot.
We will conduct subgroup analyses:
i) restricting to randomized controlled parallel-group trials.
ii) excluding trials whose sample sizes are predominantly large compared with the other trials.

Management information
Registered date
2017 Year 11 Month 14 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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