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A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium

A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium - A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058497
Enrollment
24
Registered
2025-07-17
Start date
2025-07-16
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

Healthy adults

Interventions

Intake the test food (supplement A) for 4 weeks, then take another test food (supplement B) for 4 weeks after washout. Intake of test food (dairy drink A) for 4 weeks, then take another test food (dai

Sponsors

NISSIN YORK CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects aged 20 to 65 at the time of obtaining consent 2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery 3.Subjects who are suffering from or have a history of a disease that may affect defecation 4.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator 5.Subjects who have used antibiotics within the past month 6. Subjects who have continuously consumed foods containing bifidobacterium within the past 3 months 7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period 8. Subjects with smoking habits 9. Subjects with irregular lifestyles due to night shifts 10. Subjects who have allergies to the test food 11.Female subjects who are pregnant or lactating, or intending to become pregnant during the study 12.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 13. Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Fecal short-chain fatty acid concentrations before and after ingestion of each test food

Secondary

MeasureTime frame
Gut microbiota before and after ingestion of each test food bowel movement status (frequency, amount, stool characteristics, defecation condition, feeling of refreshment) for one week before and after ingestion of each test food

Countries

Japan

Contacts

Public ContactSenami Nishida

NISSIN YORK CO., LTD. Development Laboratories

senami.nishida@nissin.com048-565-4686

Outcome results

None listed

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