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Safety evaluation of excessive intake of a functional food containing lactic acid bacteria in healthy adults.

Safety evaluation of excessive intake of a functional food containing lactic acid bacteria in healthy adults. - Safety evaluation of excessive intake of a functional food containing lactic acid bacteria.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025711
Enrollment
20
Registered
2018-02-26
Start date
2017-01-24
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

Test beverages (containing lactic acid bacteria) Duration: 4 weeks Negative control beverages Duration: 4 weeks

Sponsors

Asahi Group Holdings, Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Japanese untreated males and females from 20 to 69 years of age. (2) Individuals who are judged as suitable for the study based on the results of preliminary clinical and physical examination. (3) Individuals who can have an examination in a designated day (4) Individuals who gave the written informed consent before the study.

Exclusion criteria

Exclusion criteria: (1) Individuals who have hepatic disorders, renal and/or heart failure, organ damages, and/or other severe disorders. (2) A surgical history of digestive system (except appendicectomy) (3) Individuals who undergo medical treatment for chronic diseases. (4) Individuals who are pregnant or have possibility to become pregnant during the study or breast-feeding. (5) Individuals who drink alcohol a lot. (6) Individuals who have tendency to get diarrhea by consuming milk or lactic acid bacteria. (7) With allergy to milk and/or soybean. (8) Individuals judged as unsuitable for the study by the principal investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
The incidence of side effects during intervention

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation PI-Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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