Healthy adult with a tendency for constipation
Conditions
Interventions
Ingest probiotics food:BFF004 three times a day, 1 package after meals for 2 weeks.
Ingest probiotics food:BFF003 three times a day, 1 package after meals for 2 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females from 20 to 64 years of age. (2)Subjects with a tendency for constipation at three to five times of defecation per week at the point of screening examination. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: (1)Subjects who falls in more than half a week to Bristol scale 1. (2)Subjects who taking medicine. (3)Subjects who taking health foods which is said to improve constipation at the point of screening examination. (4)Subjects who having been taken ntestinal preparation and/or antibacterial drug within 2 weeks at the point of screening examination. (5)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. (6)Subjects who consuming large amounts of alcohol on a daily basis. (7)Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation. (8)Subjects who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire. (9)Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (10)Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (11)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 16S rRNA metagenome analysis by next generation sequencer of intestinal bacterial flora. Intestinal metabolite (metabolome analysis). Satisfaction (VAS). | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed