UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029963
Receipt number 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 2023/01/11 10:42:35

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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

g167_0@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

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

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

toshika_okuni@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

2023 Year 01 Month 11 Day



Link to view the page

Value
https://center6.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