MedPath

A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium

Not Applicable
Conditions
Healthy adults
Registration Number
JPRN-UMIN000034010
Lead Sponsor
CPCC Company Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who didn't undergo abdominal surgical operation within 6 month before the test. (2) Subjects who didn't take antibiotics within 1 month before the test. (3) Subjects who have allergy to test food. (4) Subjects who are heavy drinkers of alcohol. (5) Subjects who plan big change of lifestyle during the test. (6) Subjects with tendency of chronic diarrhea. (7) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver functions, kidney functions, cardiovascular system and digestive systems. (8) Subjects who suspected serious infectious disease. (9) Females who are pregnant (including the possibility of pregnancy) or are lactating. (10) Subjects who have participated the other clinical test within 1 month before the test. (11) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination. (12) Subjects who have a plan to start consuming medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) during examination. (13) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (14) Males who donated over 400mL blood within the last 3 months to the current study. (15) Females who donated over 400mL blood within the last 4 months to the current study. (16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (18) Others they have been determined ineligible by principal investigator or sub-investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath