Healthy adult
Conditions
Interventions
Intake of 3 test drinks per day. Each test drink containing B. lactis GCL2505(concentration of 1X10^10CFU) and inulin (2g) for 4 weeks.
Intake of 3 placebo drinks (not containing B. lactis GCL2505 and
Sponsors
CPCC Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and female aged over 20 to 59 years old when acquisition consent. (2) Subjects who take regular meals three times a day. (3) Subjects who can abstain from alcohol 2 days before each test. (4) Subjects who do not repeat constipation and diarrhea on a daily basis. (5) Subjects who do not have serious complications. (6) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who have lactose intolerance. (2) Subjects who can't refrain restricted and/or prohibited foods during the test. (3) Subjects who take medications that affect intestinal environment, digestion and absorption at the time of advance inspection. (4) Subjects who regularly use laxatives, intestinal regulator, etc. (5) Pregnant or possibly pregnant, or lactating women. (6) Subjects who have a history of and/or current medical history of severe diseases such as heart, liver, kidney, digestive organs, drug dependence, alcohol dependence. (7) Subjects who excessive alcohol intake. (8) Subjects who have extremely irregular life rhythms, and have midnight work or irregular shift work. (9) Subjects who have previous medical history of drug and/or food allergy. (10) Subjects who have chronic illness and regularly use medicines. (11) Subjects who were judged unsuitable for the clinical test from the results of the blood test at advance inspection. (12) Subjects who are participating the other clinical tests and participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (13) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (14) Males who donated over 400mL blood and/or blood components within the last three months to the current study. (15) Females who donated over 400mL blood and/or blood components within the last four months to the current study. (16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (18) Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data). (2) Presence or absence of abnormal variations in clinical test data. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Co., Ltd. Sales & Planning division
Outcome results
None listed