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A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function. - A randomized, double-blind, placebo-controlled, parallel-group comparative method -

A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function. - A randomized, double-blind, placebo-controlled, parallel-group comparative method - - A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045901
Enrollment
200
Registered
2022-09-08
Start date
2021-10-30
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

Ingest the yogurt drink containing the target lactic acid bacteria every day for 12 weeks. Ingest the yogurt drink without the target lactic acid bacteria every day for 12 weeks.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese males and females aged from 20 to 64 years old. 2. Subjects who often catch colds or get poor physical conditions. 3. Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.

Exclusion criteria

Exclusion criteria: Subjects (who) 1. suffering from, undergoing treatment for, or with a history of serious diseases. 2. have chronic diseases and take medication on a daily basis. 3. have been diagnosed as dry mouth. 4. are unable to abstain from taking supplement, food for specified health use or functional food, or health food that may affect immune function. 5. are unable to abstain from taking food that containing lactic acid bacteria, bifidobacterium, oligosaccharides, or viable bacteria during the study. 6. consistently drink more than the appropriate amount of alcohol. 7. are unable to abstain from alcohol for 2 days prior to screening test and each test. 8. have food allergies. 9. take or have the plan to take medicine for pollen allergy. 10. with digestive diseases affecting digestion and absorption and with a history of digestive surgery (excluding appendicitis). 11. tend to get diarrhea by taking dairy products. 12. are pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding. 13. are judged to be inappropriate as research subjects by blood tests in screening tests. 14. have a history or current condition of drug or alcohol dependence. 15. are participating in research involving the ingestion of other foods or the use of other medicines or who have participated within one month of obtaining consent, and those who are willing to participate. 16. are judged to be inappropriate as research subjects by the principal investigator. 17. smoke 21 or more cigarettes a day. 18. have the plan to receive the influenza vaccine from 3 weeks before ingestion to the end of the ingestion period. 19. have the plan to receive the COVID-19 vaccine during the ingestion period. 20. work on night shift. 21. plan to travel abroad during the study. 22. has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components.

Design outcomes

Primary

MeasureTime frame
Physical health questionnaire (local symptoms, systemic symptoms, general symptoms)

Secondary

MeasureTime frame
Salivary sIgA (concentration, secretion rate, secretion amount) NK cell activity Serum IgA level Serum IgG level Serum d-ROMs level Serum BAP level Body temperature POMS 2 Adult Forms

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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