Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Food containing coated bifidobacteria Administration: Take one packet with water or as it is and swallow it without chewing *If you forget to take the test food, t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects who have relatively low bifidobacteria
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who have chronic constipation 11. Subjects who have other diseases that may significantly affect bowel movement, or who have a medical history of them 12. Subjects whose do not have bifidobacteria at Scr 13. Subjects who usually take foods containing rich in lactic acid bacteria, health foods fortified with lactic acid bacteria (such as yogurt and lactic acid bacteria beverages or dietary supplements), or medicines 14. Subjects who usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber) 15. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The intestinal flora at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and CAS score in the Japanese Version of the Constipation Assessment Scale Middle Term version (CAS-MT) at 4w 2. The numbers of defecation days, the defecation frequency, and the amount of defecation in period 3~6* 3. Stool shape, stool color, stool smell, and exhilarating feeling of defecation in period 3~6* 4. The abdominal discomfort in period 1~4* 5. Each item of CAS-MT at 4w *Period 1: Seven days prior to screening (before consumption: Scr) Period 2: Seven days prior to pre-consumption assessment Period 3: The 1st week after consumption of the test food Period 4: The 2nd week after consumption of the test food Period 5: The 3rd week after consumption of the test food Period 6: The 4th week after consumption of the test food | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed