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Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults

Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults - Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021511
Enrollment
44
Registered
2016-03-17
Start date
2016-03-17
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 with or without a tendency for constipation

Interventions

Intervention Test tablets (containing lactic acid bacteria powder) Duration: 4 weeks Amount: 4.4 g daily Control Placebo tablets Duration: 4 weeks Amount: 4.4 g daily

Sponsors

Clinical Support Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Japanese untreated males and females from 20 to 69 years of age. (2) Those judged as suitable for the study by the principal investigator. (3) Those who gave the written informed consent before the study.

Exclusion criteria

Exclusion criteria: (1) A medical history of severe disorders, or continuous medical treatment. (2) A surgical history of digestive system (except appendicectomy) (3) Constantly usage of medical agents for constipation, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) for intestinal regulation. (4) With allergy to lactic acid bacteria, milk, soybean, or citrus/ (5) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding. (6) Those who drink alcohol a lot or heavy smoker. (7) Those having an extremely irregular diet habit (unexpectedly skipping three or more meals a week) (8) Alternative work schedule, or work on midnight shift. (9) Those who are participating or plan to participate the other clinical tests (foods, medicines, cosmetics or liniments) during the study. (10) Those 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