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A study for evaluating the effects of oral intake of lactic acid bacteria on immune function. A randomized, double-blind, placebo- controlled trial.

A study for evaluating the effects of oral intake of lactic acid bacteria on immune function. A randomized, double-blind, placebo- controlled trial. - A study for evaluating the effects of oral intake of lactic acid bacteria on immune function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020307
Enrollment
100
Registered
2015-12-24
Start date
2015-12-25
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

None (Healthy adults)

Interventions

Lactic acid bacteria, 1 portion of food per day for 4 weeks. Placebo (not containing lactic acid bacteria), 1 portion of food per day for 4 weeks.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Males and females aged from 20 to less than 65 years old, when giving the informed consent. 2)Individuals who have low activities of immune cells in peripheral blood. 3)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.

Exclusion criteria

Exclusion criteria: 1)Individuals who can't stop drinking for 2 days until the screening and each checkup. 2)Individuals who can't stop eating foods containing lactic acid bacteria and oligosaccharide during this study. 3)Individuals who can't stop eating foods which may activate immune functions. 4)Individuals who have tendency to get diarrhea by eating dairy product. 5)Individuals who have a history of irritable bowel syndrome and Crohn's disease. 6)Individuals who was vaccinated and who may receive it this year. 7)Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 8)Individuals who have chronic diseases and use medicines continuously. 9)Individuals who have under treatment or a history of drug addiction and/or alcoholism. 10)Individuals who are judged as unsuitable for the study based on the results of blood test. 11)Individuals with excessive alcohol-drinking behaviors. 12)Individuals who have a medical history of diseases affecting digestion and absorption. 13)Individuals who have a medical history of hay fever. 14)Individuals having food allergy. 15)Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. 16)Individuals who are participating or willing to participate in other clinical trials or in the last 3 months. 17)Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods. 18)Individuals who are judged unsuitable for this study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Evaluation of cytokines production and expression levels of anti-viral genes of peripheral blood mononuclear cells stimulated by viruses at 4 weeks after intervention.

Secondary

MeasureTime frame
Activities of dendritic cells in peripheral blood at 4 weeks after intervention. (Cell surface expression levels of dendritic cells makers.)

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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