A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.-A randomized, double-blind,placebo-controlled, parallel-group comparative study

Not Applicable

• Conditions: Subjects with a tendency for constipation

• Registration Number: JPRN-UMIN000048911
• Lead Sponsor: ew drug research center, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-10
• Study Start: 2023-12-04
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects taking medicines/foods that affect the intestinal environment at least 3 times a week. 2) Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 3) Subjects with chronic diseases and regular users of medicines. 4) Subjects with a history or current history of drug or alcohol dependence 5) Subjects with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6) Subjects with food allergies related to the test food. 7) Subjects with extremely irregular daily habits and eating habits (including late-night workers). 8) Subjects who regularly use medicines or foods that affect the study. 9) Subjects who cannot restrict the use of drugs/foods that affect the study after obtaining consent. 10) Subjects with excessive habits of exercise, drinking and smoking. 11) Pregnant or lactating women or women who may become pregnant during the study period. 12) Subjects who have taken or will take antibiotics within 1 month prior to obtaining consent during the study period. 13) Participated, are currently participating, or will participate during the study period, in any other clinical research within 1 month prior to obtaining consent. 14) Subjects who plan to change their lifestyle drastically after obtaining consent and before the end of the study. 15) Subjects who plan to travel abroad after obtaining consent and before the end of the study. 16) Subjects judged to be unsuitable based on their answers to the background questionnaire. 17) Other subjects who are judged by the investigator to be unsuitable for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified