Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test food: Capsule containing butyrate-producing bacteria Administration: Take three capsules per day with water *If you forget to take the test food, take it as soon as you r
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 whose defecation frequency is few in seven days prior to Scr
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, rheumatoid arthritis, 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" 5. Subjects who take foods or medicines containing butyrate-producing bacteria (Clostridium butyricum) 6. Subjects who are taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 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 are judged inappropriate as participants from answers to lifestyle questionnaires 11. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period 3* * Period 3: 8~14 days after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of numbers of butyrate-producing bacteria (Clostridium butyricum) at two weeks after consumption (2w) 2. The amount of change from screening (before consumption; Scr) of numbers of butyrate-producing bacteria (Clostridium butyricum) at 2w 3. The defecation frequency in period 2* 4. The defecation days and amount of defecation in period 2 and 3* 5. The stool shape, stool smell, and exhilarating feeling of defecation in period 2 and 3* 6. The score of the Japanese Version of the Constipation Assessment Scale [middle term] (CAS-MT) at 2w 7. Each item of CAS-MT at 2w 8. The occupancy rate of bacteria in the stool and the diversity index (Chao1, Shannon, ACE, Jackknife, NPShannon, Simpson, Phylogenetic Diversity) at 2w 9. Short-chain fatty acid levels (acetic acid, propionic acid, and butyric acid) in the stool 10. Short-chain fatty acid levels (acetic acid, propionic acid, and butyric acid) in the blood * Period 1: The seven days prior to Scr Period 2: The seven days after initial consumption Period 3: 8~14 days after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed