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

KSO Corporation0 sites40 target enrollmentApril 5, 2024

Overview

No summary available.

Registry

who.int

Start Date

April 5, 2024

End Date

November 2, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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.