UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054696 |
|---|---|
| Receipt number | R000062506 |
| Scientific Title | Validation of the method for measuring stool consistency, using a texture analyser (TA.XT Express Texture Analyser) |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/12/19 11:43:15 |
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Basic information
Public title
Validation of the method for measuring stool consistency, using a texture analyser
Acronym
Validation of the method for measuring stool consistency, using a texture analyser
Scientific Title
Validation of the method for measuring stool consistency, using a texture analyser (TA.XT Express Texture Analyser)
Scientific Title:Acronym
Validation of the method for measuring stool consistency, using a texture analyser (TA.XT Express Texture Analyser)
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of measurement for stool consistency by investigating correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content, and investigation of relationship between various defecation-related parameters.
Basic objectives2
Others
Basic objectives -Others
Correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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).
Key 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Haruna |
| Middle name | |
| Last name | Yamashita |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
yamashita.haruna@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute, Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Validation of measurement for stool consistency by investigating correlations of TAXT measurement with participant/expert- Bristol Stool Form Scale and stool water content, and investigation of relationship between various defecation-related parameters.
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062506
