JRCT ID: jRCTs031200138
Registered date:09/10/2020
A Confirmation Study of the Viability of Combined Probiotic Strains
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Not applicabl |
Date of first enrollment | 09/10/2020 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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. |
Outcome(s)
Primary Outcome | Time series of fecal viable bacterial counts (by study drug) |
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Secondary Outcome | Time series of fecal organic acids (by study drug) Time series of the recovery rate of viable bacteria (by study drug) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 65age old |
Gender | Male |
Include 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 |
Exclude 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) |
Related Information
Primary Sponsor | Kunishige Hideyuki |
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Secondary Sponsor | Biofermin Pharmaceutical Co., Ltd. |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Ryo Kanamori |
Address | Higasi2-1-30,Atsubetsuhigashi4-jo, Atsubetsu-Ku,Sapporo,Hokkaido Hokkaido Japan 004-0004 |
Telephone | +81-80-6082-7362 |
chiken-be@hpgr.jp | |
Affiliation | Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital |
Scientific contact | |
Name | Hideyuki Kunishige |
Address | Higasi2-1-30,Atsubetsuhigashi4-jo, Atsubetsu-Ku,Sapporo,Hokkaido Hokkaido Japan 004-0004 |
Telephone | +81-11-898-2151 |
chiken-be@hpgr.jp | |
Affiliation | Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital |