A verification study on the effects of a beverage containing the probiotic Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation.

UMIN ID: UMIN000054577

Registered date:05/06/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/05/07
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The volunteers are treated for four weeks with a 100 mL drink containing Lactococcus 11/19-B1 (10 billion bacterial cells/100 mL) once daily.
The volunteers are treated for four weeks with a 100 mL drink without Lactococcus 11/19-B1 once daily.

Outcome(s)

• Primary Outcome: Nasal mucociliary clearance time(saccharin tests)
• Secondary Outcome: Blood natural killer (NK) cell activity, blood cytokine levels, blood biochemical parameters, self-reported throat discomfort (irritating, dry throat)

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who have a current or past history of serious illness. 2. Subjects who regularly consume commercially available drugs, quasi-drugs, supplements, foods for specified health uses, and foods with functional claims. 3. Subjects with a current or past history of drug or food allergies. 4. Subjects who have donated component blood or 200 mL of whole blood within one month of the start of this study. 5. Subjects who have donated 400 mL of whole blood within 4 months of the start of this study. 6. Subjects who have participated in or are currently participating in other clinical trials or research within one month before obtaining consent or those who plan to participate during the study period. 7. Subjects who are currently pregnant or breastfeeding or those who wish to become pregnant during the study period. 8. Subjects who drink a lot of alcohol daily (60g/day in terms of alcohol). 9. Subjects with irregular lifestyles, such as those with extremely irregular eating habits, those who work shifts, or those who work late at night. 10. Subjects judged by the study director to be unsuitable for participation in this study. 11. Subjects with a smoking habit within the past 2 years.

Related Information

• Primary Sponsor: Kyodo Milk Industry Co., Ltd.
• Source(s) of Monetary Support: Kyodo Milk Industry Co., Ltd.