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Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Not Applicable
Conditions
Healthy 20s female
Registration Number
JPRN-UMIN000052725
Lead Sponsor
Ebara Foods industry,Inc. Creative Division Research Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Persons who cannot restrict the use of medicines (laxatives, bowel regulators, etc.), health foods, foods for specified health uses, foods with functional claims, health supplements, supplements, etc. that may affect bowel movements, and foods that contain a large amount of lactic acid bacteria after the time consent is obtained (2) Those who are currently receiving medication or outpatient treatment for various illnesses that prevent them from leading a daily life. (3) Persons who are currently under the supervision of a physician for exercise or diet therapy. (4) Persons who are at risk of developing food allergies due to the test foods. (5) Persons with a current or previous history of drug or alcohol dependence. (6) Persons with extremely irregular rhythm of life (eating, sleeping, extremely picky eaters, etc.) (7) Those who are in the hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or have a history of mental illness in the past. (8) Those who have participated in other clinical trials (research) within 3 months prior to the date of consent, or have plans to participate in other clinical trials (research) during the study period.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intestinal microflora analysis (conducted twice, before and after ingestion of test product) Stool record (recorded daily during the study period, including one week before and after the intake period)
Secondary Outcome Measures
NameTimeMethod
ifestyle survey (recorded every week during the study period, including one week before and after the intake period) Weight and body composition (conducted twice before and after the intake period)
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