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

Validation of the method for measuring stool consistency, using a texture analyser (TA.XT Express Texture Analyser) - Validation of the method for measuring stool consistency, using a texture analyser (TA.XT Express Texture Analyser)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054696
Enrollment
40
Registered
2024-06-18
Start date
2024-07-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Interventions

None listed

Sponsors

Healthcare Systems Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Persons who received a sufficient explanation of the purpose and contents of the exam,have the capacity to consent,applied with free will with sufficient understanding,and agreed to participate. 2)Persons who are healthy women or men aged 18 years (inclusive) or older. 3)Persons who are willing and able to provide at least 3 stool samples during 2 collection periods of 3 days prior to sample collection date to immediately prior to collection,to store the samples in appropriate conditions and to return the samples within the required timeframe. 4)Persons who are willing and able to complete a diary during the study periods in order to collect information about form of the stools (based on the Bristol Stool Form Scale classification), bowel habit and sleep habit,dietary habit,exercise habit. 5)Persons who understand the Japanese language (reading,writing and speaking).

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHaruna Yamashita

Healthcare Systems Co., Ltd. Clinical Research Department

yamashita.haruna@hc-sys.jp03-6809-2722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026