UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057541 |
|---|---|
| Receipt number | R000065744 |
| Scientific Title | The study of the changes in defecation information by ingestion of prebiotic foods |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/07 18:45:29 |
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Basic information
Public title
The study of the changes in defecation information by ingestion of prebiotic foods
Acronym
The study of the changes in defecation information by ingestion of prebiotic foods
Scientific Title
The study of the changes in defecation information by ingestion of prebiotic foods
Scientific Title:Acronym
The study of the changes in defecation information by ingestion of prebiotic foods
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the changes in defecation information by constant ingestion of prebiotic foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation-related indicator
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After 3 weeks of eating their normal diet, they consumed the test foods for 7 weeks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those whose workplace is the TOTO Research Institute on the date of consent
2. Those who have received sufficient explanation about the purpose and content of this study, have the ability to consent, fully volunteered with voluntary intention, agreed to participate
3. Those who come to work at least twice a week and have the habit of defecation during the day
Key exclusion criteria
1. Those who are classified as having chronic constipation according to the ROME IV criteria
2. Those who have digestive disorders such as irritable bowel syndrome and reflux esophagitis
3. Those who take statin drugs for dyslipidemia, gastric acid suppressants, or blood sugar sclerosing drugs
4. Those who judge as unsuitable for the study by the principal investigator or research physician for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Oba |
Organization
TOTO LTD. Research Institute
Division name
Universal Design and lifestyle Research Department
Zip code
253-8577
Address
2-8-1, Honson, Chigasaki-City, KANAGAWA Pref., JAPAN
TEL
0467-54-3380
masayuki.oba@jp.toto.com
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Hosokawa |
Organization
TOTO LTD. Research Institute
Division name
Universal Design and lifestyle Research Department
Zip code
253-8577
Address
2-8-1, Honson, Chigasaki-City, KANAGAWA Pref., JAPAN
TEL
0467-54-3387
Homepage URL
ayano.hosokawa@jp.toto.com
Sponsor or person
Institute
TOTO LTD. Research Institute
Institute
Department
Personal name
Funding Source
Organization
TOTO 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
Research Institute of Human Engineering for Quality of life
Address
1-11-4-1600, Umeda 1-chome, Kita-ku, Osaka-shi, OSAKA Pref., Japan, Osaka Station Square Fourth Building, Floor16 6-611
Tel
06-6346-9912
hql-rinri-j@hql.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
| 2025 | Year | 04 | Month | 21 | 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
30
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 | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065744
