UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047933 |
|---|---|
| Receipt number | R000054636 |
| Scientific Title | Investigation for intestinal bacteria and their metabolites associated with variability of defecation intervals |
| Date of disclosure of the study information | 2022/06/02 |
| Last modified on | 2025/02/20 17:41:54 |
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Basic information
Public title
Investigation for intestinal bacteria and their metabolites associated with variability of defecation intervals
Acronym
Investigation for intestinal bacteria and their metabolites associated with variability of defecation intervals
Scientific Title
Investigation for intestinal bacteria and their metabolites associated with variability of defecation intervals
Scientific Title:Acronym
Investigation for intestinal bacteria and their metabolites associated with variability of defecation intervals
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the intestinal factors associated with defecation intervals
Basic objectives2
Others
Basic objectives -Others
To investigate the gut microbiota and their metabolites associated with defecation intervals
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the gut microbiota and their metabolites associated with defecation intervals
Key secondary outcomes
To evaluate the correlation of "defecation intervals" and "stool characteristics, bowel habits, whole gut transit time, and symptoms during defecation"
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1.Subjects regularly taking laxatives or antibiotics
2.Subjects participating in any other studies with intervention or restriction of food intake, or completing such studies within one week
3.Subjects weighing less than 50kg
4.Subjects judged as unsuitable for study participant (e.g. subjects unable to collect feces according to the schedule)
5.Subjects who had a fever or cold symptoms within the month prior to the informed consent.
6.Subjects who lived with a person who had a fever or cold symptoms within the month prior to the informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sato |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8912
tadashi-sato@yakult.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Saito |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8912
Homepage URL
yuki-saito@yakult.co.jp
Sponsor or person
Institute
Yakult Central Institute
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Bldg. 3-3-10, Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2022 | Year | 06 | Month | 02 | 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
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
The protocol was revised and approved on June 30.
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054636
