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Safety evaluation of long-term intake of drink containing lactic acid bacteria for healthy adults.

Safety evaluation of long-term intake of drink containing lactic acid bacteria for healthy adults. - Safety evaluation of long-term intake of drink containing lactic acid bacteria for healthy adults.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035691
Enrollment
20
Registered
2019-01-28
Start date
2019-01-29
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 adult

Interventions

Intake of test product for 12 consecutive weeks

Sponsors

TTC Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females from 20 to 64 years of age (2)Subjects falling under any of the following answer of the lifestyle questionnaire in the preliminary examination A.Subjects with a tendency for constipation at three to five times of defecation per week B.Subjects with a tendency for constipation at seven times of defecation per week

Exclusion criteria

Exclusion criteria: (1)Subjects judged as unstable for this study based on the results of clinical examination or cardiopulmonary abnormality (2)Subjects have possibilities to develop an allergy to the test product (3)Subjects have a disease requiring regular medication or a history of serious diseases for which medication was required (4)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5)Subjects who have participated in other clinical studies (6)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (7)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8)Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Hematologic test Biochemical test Urine analysis Blood pressure/Pulse rate Weight/body mass index Doctor's questions Adverse event Evaluate at points of 4,8 and 12weeks of ingestion and 4weeks after the end of ingestion period

Countries

Japan

Contacts

Public ContactTamaki Furuhata

TTC Co., Ltd Clinical Research Planning Department

t.furuhata@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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