A study to confirm the safety of long-term intake of bifidobacteria : a placebo-controlled, randomized, double-blind study. - A study to confirm the safety of long-term intake of bifidobacteria.

KSO Corporation0 sites30 target enrollmentSeptember 30, 2023

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: KSO Corporation
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 30, 2023

End Date

March 25, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

KSO Corporation

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Subjects who regularly take oral medicine (especially laxatives, antiflatulents, laxatives, etc. that affect bowel movements). 2\. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment. 3\. Subjects who have chronic disease and is under medication. 4\. Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (Excluding appendicitis). 5\. Subjects who are suffering from other serious diseases. 6\. Subjects who are not able to stop ingesting foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods that are said to be good for improving constipation, foods containing large amounts of sugar alcohol, during the study period. 7\. Subjects who are consuming large amounts of alcohol (abouts 40 g or more in terms of pure alcohol) on a daily basis. 8\. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 9\. Subjects who have food and medicine allergy. 10\. Subjects who are pregnant or breast\-feeding, or have the will of pregnancy during the study period. 11\. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 12\. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.