A clinical study for evaluating the safety of excessive intake of fermented milk drink. -Open study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000024347
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Subjects who regularly use intestinal drugs or laxatives. 2) Subjects who have severe complication or serious diseases requiring an urgent treatment. 3) Subjects who have a chronic disease and use medicines constantly. 4) Subjects who have medical history of diseases or surgeries which affect digestion and absorption. 5) Subjects who repeat constipation and diarrhea such as irritable colitis. 6) Subjects who regularly use functional foods which help relieve constipation (including Food for Specified Health Uses, Foods with Function Claims) 7) Subjects who take drugs which affect digestion and absorption such as antibiotics at screening test. 8) Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria, large amounts of sugar alcohol or functional foods (including Food for Specified Health Uses, Foods with Function Claims) which help relieve constipation. 9) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 10) Subjects who have tendency to get diarrhea by ingesting milk. 11) Subjects who have food allergy. 12) Subjects who are judged as unsuitable for the study by screening questionnaire. 13) Subjects who are judged as unsuitable for the study by the blood test results of screening test. 14) Subjects who are planning to become pregnant during the study or are pregnant or lactating. 15) Subjects who are planning to participate or already participating in other clinical studies. 16) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method