Healthy adult
Conditions
Interventions
Consumption of fermented milk drink, 3-fold quantity of recommended daily intake, for 4 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy men and women aged 20 to 64 years old. 2) Subjects who tend to be constipated (defecation frequency is 3-5 times per week) or have daily defecation. 3) Subjects who eat 3 meals regularly in one day. 4) Subjects who can stop drinking from 2 days before each inspection date. 5) Subjects who understand details of the study and provides informed consent by documents.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview Adverse event | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed