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Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment: a systematic review with meta-analysis

Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment: a systematic review with meta-analysis - Effects of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement and intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000038611
Enrollment
100
Registered
2021-12-31
Start date
2019-11-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

KAGOME CO., LTD.
Lead Sponsor
Review Team Professor Hiroharu Kamioka, Department of Ecological Symbiotic Science, Tokyo University of Agriculture Ms. Mari Makishi, NARASHINO Media Center for Research &amp
Collaborator
Education, Media Net Center, TOHO University. Mr. Yudai Aoki, Innovation Division, KAGOME CO., LTD. Ms. Kei Mukuta, Innovation Division, KAGOME CO., LTD.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: We will exclude proceedings and unpublished studies which don't give us enough research details.

Design outcomes

Primary

MeasureTime frame
We will evaluate the effect of Bifidobacterium animalis subsp. lactis BB-12 intake on bowel movement frequency.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactTakuro Inoue

KAGOME CO., LTD. Innovation Division

g167_0@kagome.co.jp+81287362935

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026