NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2018/11/28
Target sample size	70
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Daily intake of 1 capsule containing heat-killed Lactobacillus plantarum HOKKAIDO for 8 weeks. Daily intake of 1 capsule containing dextrin for 8 weeks.

Outcome(s)

Primary Outcome	NK-cell activity at 4 and 8 weeks after beginning the intake of test food.
Secondary Outcome	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.

Key inclusion & exclusion criteria

Age minimum	30years-old
Age maximum	50years-old
Gender	Male and Female
Include criteria
Exclude 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.