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Dose-finding study of drink-A containing lactic acid bacteria

Not Applicable
Conditions
Subjects who have a tendency to be constipated
Registration Number
JPRN-UMIN000026589
Lead Sponsor
QOL RD Co.,Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

(1)Males and females from 20 to 70 years-old (2)Subjects who have a tendency to be constipated defecate two to five times a week (3)Subjects undergoing none of medical treatments (4)Subjects eat regularly (1)Subjects with a serious disease (2)Subjects have a medical history or a surgical history of digestive diseases (3)Subjects allergic to a specific drug or food (4)Subjects work alternative or midnight shifts (5)Subjects never be able to stop intaking foods or drinks which improve constipation during study,such as foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers and/or other health foods including food for specified health use (6)Subjects who have any kinds of drugs affect this study (constipation drugs, intestinal drugs, etc.) (7)Subjects drink alcohol over 500mL in terms of beer per day (8)Subjects smoke over 20 cigarettes per day (9)Subjects drawn blood over 200mL last 1 month, or over 400mL last 3 months (10)Subjects allergic to samples in this study (11)Pregnants, lactating women or who is going to be pregnant (12)Subjects who have participated in the other clinical studies (13)Subjects judged as unsuitable for the study by the principal investigator for other reasons

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Defecation frequency, fecal amount
Secondary Outcome Measures
NameTimeMethod
Fecal shape, fecal color, feelings after defecation, analysis of intestinal microflora
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