healthy subjects
Conditions
Interventions
Subjects eat food containing lactic acid bacteria for 4 weeks
Sponsors
EZAKI GLICO Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who eat three regular meals 2) Subjects who can abstain from alcohol for 2 days prior to each examination 3) Subjects who don't have recurrent episodes of constipation and diarrhea 4) Subjects who don't have any serious complications
Exclusion criteria
Exclusion criteria: 1) Subjects who are suffering or undergoing treatment or with a history of diabetes mellitus, renal or hepatic disease, cardiac disease or other serious disease, thyroid disease, adrenal disease, psychiatric disease, autoimmune disease, or other metabolic disease (excluding subjects who approved by the principal investigator to participate in the study) 2) Subjects who are lactose intolerant 3) Subjects who can't stop taking foods containing lactobacilli, bifidobacteria, oligosaccharides, or other live bacteria during the study 4) Subjects who regularly eat supplements or health foods (including food for specified health uses) that may affect immunity 5) Subjects who have taken antibiotics within one month of the study 6) Subjects who are regularly taking laxatives, intestinal preparations, etc. 7) Subjects who are pregnant, intend to become pregnant during the research period, or are breastfeeding 8) Subjects who are constantly consuming alcohol over the appropriate level (an average of approximately 20 g of pure alcohol per day) 9) Subjects who are allergic to medicines or food 10) Subjects who have chronic diseases and regularly use medicines 11) Subjects who have a history of gastrointestinal diseases affecting digestion and absorption or a history of gastrointestinal surgery (excluding appendicitis) 12) Subjects who have no abnormal blood test results from a physical examination within the past year 13) Subjects who are suffering from an illness that requires urgent treatment 14) Subjects with a history or current history of drug or alcohol dependence 15) Subjects who are currently participating or intend to participate in a study (trial) involving the ingestion of other foods or the use of medicines, or the application of cosmetics or pharmaceuticals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of eating food containing lactic acid bacteria for 4 weeks | — |
Countries
Japan
Contacts
Public ContactKana Nishimura
EZAKI GLICO Co., Ltd. R&D LABORATORY
Outcome results
None listed