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Effect of Daily Intake of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Effect of Daily Intake of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study - Beneficial Effects of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034822
Enrollment
70
Registered
2018-11-09
Start date
2018-11-28
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

Daily intake of 1 capsule containing heat-killed Lactobacillus plantarum HOKKAIDO for 8 weeks. Daily intake of 1 capsule containing dextrin for 8 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Subjects who agree to participate in this study with a written informed consent. 2.Subjects who show relatively low NK cell activity

Exclusion criteria

Exclusion criteria: 1.Subjects with serious diseases and/or infections. 2.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 3.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 4.Subjects with severe anemia. 5.Pre- or post-menopausal women complaining of obvious physical changes. 6.Subjects who are at risk of having allergic reactions to drugs or foods. 7.Subjects who regularly intake products containing HOKKAIDO-strain. 8.Subjects who regularly take medicine, functional foods, and/or supplements which would affect immune function. 9.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 10.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 11.Pregnant or lactating women or women who expect to be pregnant during this study. 12.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 13.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
NK-cell activity at 4 and 8 weeks after beginning the intake of test food.

Secondary

MeasureTime frame
IgA, IgG, IgM, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophil-lymphocyte ratio, salivary s-IgA VAS questionnaire assessed condition of gastrointestinal tract and fatigue, frequency of common cold symptoms.

Countries

Japan

Contacts

Public ContactJun NISHIHIRA

Hokkaido Information University Health Information Science Research Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

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