A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial. - A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment.

KSO Corporation0 sites22 target enrollmentNovember 29, 2019

ConditionsSubjects with a tendency for constipation

Overview

Phase: 未知
Intervention: Not specified
Conditions: Subjects with a tendency for constipation
Sponsor: KSO Corporation
Enrollment: 22
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

November 29, 2019

End Date

March 7, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

KSO Corporation

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•(1\) Individuals taking antiflatulents and/or laxatives (including purgative drug) in common use (2\) Individuals taking health foods in common use, which influence intestinal regulation at the point of screening examination (3\) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4\) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period (5\) Individuals presenting known food allergy (6\) Individuals taking large amounts of alcohol on a daily basis (7\) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8\) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9\) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (10\) Individuals who are pregnant or breast\-feeding, or have the will of pregnancy during the study period (11\) Individuals who are under treatment or have a history of drug/alcohol dependence (12\) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (13\) Individuals who are judged as unsuitable for the study by the investigator for the other reasons