A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-

UMIN ID: UMIN000053242

Registered date:05/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Male/female adults
• Date of first enrollment: 2024/05/24
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of the test food (1 sachet a day) for 12 weeks
Consumption of the placebo food (1 sachet a day) for 12 weeks

Outcome(s)

• Primary Outcome: Questionnaire Physical measurement (height, weight (BMI)) Blood pressure and pulse rate Hematology Biochemistry Urinalysis Self and other symptoms Adverse events and side effects

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1.Subjects who have a history of serious illness. 2.Subjects who are under treatment with medication for chronic diseases. 3.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period. 4.Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis). 5.Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 6.Subjects who are planning to participate in other clinical studies. 7.Subjects with a history of drug allergies or severe food allergies. 8.Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study period. 9.Heavy alcohol drinkers (average of more than 20g of alcohol/day in terms of pure alcohol). 10.Excessive smokers (21 or more cigarettes per day). 11.Subjects who have been diagnosed with dry mouth. 12.Subjects who have had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period. 13.Subjects who have been deemed unsuitable as study participants by the principal investigator or sub-investigator based on their background, physical examination, blood pressure, pulse rate, and clinical test results.

Related Information

• Primary Sponsor: KSO Corporation
• Source(s) of Monetary Support: Morinaga Milk Industry Co., LTD.