Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract - Open method -

UMIN ID: UMIN000038770

Registered date:27/12/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2019/11/25
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Take Biofermin Lactic acid bacteria Supplements three times a day, one after meals, for 6 days.

Outcome(s)

• Primary Outcome: Detection of viable bacteria of Bifidobacterium bifidum F1000 in feces
• Secondary Outcome: Interview Self-resevotable symptom

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1)Subjects who having been taken intestinal preparation and/or antibacterial drug within 2 weeks at the point of screening examination. (2)Subjects who taking medicine. (3)Subjects who taking health foods that are said to improve constipation at the point of screening examination. (4)Subjects who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period. (5)Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation. (6)Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (7)Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (8)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Related Information

• Primary Sponsor: KSO Corporation
• Source(s) of Monetary Support: Biofelmin Pharmaceutical Co., Ltd