UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038611 |
|---|---|
| Receipt number | R000044005 |
| Scientific Title | Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment: a systematic review with meta-analysis |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2023/01/11 10:47:35 |
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Basic information
Public title
Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment: a systematic review with meta-analysis
Acronym
Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment
Scientific Title
Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment: a systematic review with meta-analysis
Scientific Title:Acronym
Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment
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 assess the effects of Bifidobacterium animalis subsp. lactis BB-12 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 Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement frequency.
Key secondary outcomes
We will evaluate of the effects of Bifidobacterium animalis subsp. lactis BB-12 intake on the following markers in stool sample: the occupancy of Bifidobacterium genus, the number of Bifidobacterium genus, the number of Lactobacillus group, and the number of lecithinase-positive Clostridium (Clostridim perfringens).
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 Bifidobacterium animalis subsp. lactis BB-12 or the same strain as BB-12 for more than two weeks as an intervention.
Comparison:
We define oral intake of test food not containing Bifidobacterium animalis subsp. lactis BB-12 and the same strain as BB-12, as controls.
We also define maintaining daily life as a control.
Outcome measurement:
We will evaluate bowel movement frequency as primary outcome.
We will evaluate the following markers in stool sample as secondary outcomes: the occupancy of Bifidobacterium genus, the number of Bifidobacterium genus, the number of Lactobacillus group, and the number of lecithinase-positive Clostridium (Clostridim perfringens).
(Language)
Eligibility is not restricted by language.
Key exclusion criteria
We will 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 | Takuro |
| Middle name | |
| Last name | Inoue |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
+81287362935
g167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Inoue |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
+81287362935
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
Review Team
Professor Hiroharu Kamioka, Department of Ecological Symbiotic Science, Tokyo University of Agriculture
Ms. Mari Makishi, NARASHINO Media Center for Research & Education, Media Net Center, TOHO University.
Mr. Yudai Aoki, Innovation Division, KAGOME CO., LTD.
Ms. Kei Mukuta, Innovation Division, KAGOME CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel
+813-5623-8501
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
| 2021 | 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
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Searches)
An author (e.g., MM) will search 20 databases for studies from the beginning of each database to the search date.
(Data extraction)
Two authors (e.g., YA and KM) 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., YA and KM) will independently assess the quality of articles. A full quality appraisal of these papers will be made using modified check list (13 items) of Cochrane Handbook for interventional 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 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-P, RCT-C, qRCT-P, qRCT-C, nonRCT-P, nonRCT-C, and non-randomized controlled 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 trials and randomized controlled crossover trials.
ii) restricting to randomized controlled parallel trials.
iii) excluding trials whose sample sizes are predominantly large compared with the other trials.
This is a systematic review protocol and has not been reviewed by IRB.
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | 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=R000044005
