Validation of the method for measuring stool consistency, using a texture analyser

UMIN ID: UMIN000054696

Registered date:18/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 2024/07/11
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content
• Secondary Outcome: Relationship between stool consistency, water contents, participant/expert-BSFS and other parameters: 1)bowel habit 2)sleep habit 3)stool amount 4)demographic data, dietary habits, exercise habits

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Persons who are treated (i.e., currently treated, treated within 1 month before inclusion) for constipation, diarrhea or any other illness, by use of antibiotics or any other treatment with impact on defecation. 2)Females who are pregnant, breast-feeding or intend to become pregnant. 3)Persons who have any history of drug and/or alcohol abuse. 4)Persons who have any clinically significant disease which in the investigator's opinion could interfere with the safety of study participants or with the results of the study. 5)Persons who have participated in other studies within one month before the start of the study, or those who intend to participate in another study after consenting to this study. 6)Persons who do not consent to the analysis of stool samples and the use of the results for research purposes during the course of this study.

Related Information

• Primary Sponsor: Healthcare Systems Co., Ltd.
• Source(s) of Monetary Support: Yakult Central Institute, Yakult Honsha Co., Ltd.