Not applicabl
Conditions
Interventions
Group A: New Biofermin S Tablets
Group B: New Biofermin S Plus Tablets
Group C: Biofermin Tablets
The drug in each group will be administered orally from Day 2 to Day 4.
Sponsors
Kunishige Hideyuki
Biofermin Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males aged >=20 years and <65 years who have defecation every day (average defecation frequency of 7 to 9/week in the last one month) 2. Those who usually have three meals (breakfast/lunch/dinner) a day Those who received sufficient explanation of the objectives/contents of this study and fully understood, have the ability to agree, and voluntarily provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Potential subjects with hypersensitivity to bifidobacterium or lactic acid bacteria preparations 2. Those with a history of serious disease (malignancy, heart disease, stroke, liver failure, kidney failure) 3. Those who currently have gastrointestinal disease 4. Those with a history of gastrointestinal surgery 5. Those who received intestinal regulators/antibacterial agents within 2 weeks prior to informed consent and those planning to receive intestinal regulators/antibacterial agents at any time from after the informed consent to completion of comprehensive management 6. Those who are taking oral medications 7. Those who regularly consume health foods that are considered to be good for improving constipation 8. Those who cannot comply with the restrictions of food/fluid intake other than the preset meals provided during the study period 9. Those with food allergy to preset meals provided during the study period 10. With regard to the medications used in this study and meals under comprehensive management, those who cannot, for religious reasons, etc., consume products containing ingredients without clear origin. 11. Those who are participating or plan to participate in another clinical trial/study at any time between screening and completion of this study 12. Those who were considered ineligible for the study by the investigator (or subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time series of fecal viable bacterial counts (by study drug) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time series of fecal organic acids (by study drug) Time series of the recovery rate of viable bacteria (by study drug) | — |
Contacts
Public ContactRyo Kanamori
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Outcome results
None listed