UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043940 |
|---|---|
| Receipt number | R000050161 |
| Scientific Title | The study of individual variation in feelings of bowel movement and the countermeasures |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2024/04/19 14:37:20 |
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Basic information
Public title
The study of individual variation in feelings of bowel movement and the countermeasures
Acronym
The study of individual variation in feelings of bowel movement
Scientific Title
The study of individual variation in feelings of bowel movement and the countermeasures
Scientific Title:Acronym
The study of individual variation in feelings of bowel movement
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between the effects of intestinal regulating foods and the gut microbiota
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
16S rRNA gene based metagenome analysis of gut microbiome (before and after the test period) , stool diary and lifestyle habit questionnaire
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
(1) Bifidobacterium animalis subsp. lactis GCL2505: 1*10^10 cfu, (2) Clostridium butyricum NT: 5*10^9 cfu, (3) Inulin: 2 g, (4) Manno-oligosaccharides: 3 g, and (5) Wheat bran: 12 g, are daily taken for one week, respectively. There is a one-week interval between each intervention.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females over 20 years old
Key exclusion criteria
(1) Subjects who regularly use intestinal and constipation drugs (including strong laxatives)
(2) Subjects who are heavy drinkers or alcoholics
(3) Subjects who have a disease that requires emergency treatment, or have serious complications
(4) Subjects who have a medical history of digestive diseases or surgeries affecting digestion and absorption
(5) Subjects with food allergy
(6) Subjects who are pregnant or plan to become pregnant, or breast-feeding during the study
(7) Subjects who are participating in other clinical trials that intake/apply any foods or drugs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
05017466514
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Sampei |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
05017496432
Homepage URL
masatoshi.sampei@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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 Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.com
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 | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000050161
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000050161
Number of participants that the trial has enrolled
145
Results
For all five types of test foods, we were able to create a discriminant model that determines whether a user can experience the feelings of bowel movement based on the gut microbiome data.
Additionally, it was found that 15 of the 17 subjects who suffered from constipation were able to experience the feelings of bowel movement with one of the five test foods.
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were healthy adults between the ages of 21 and 68.
Participant flow
This study is a non-randomized study, so no allocation was made. All 145 participants in the study completed the study position and the primary outcome was analyzed.
Adverse events
None
Outcome measures
16S rRNA gene based metagenome analysis of gut microbiome (before and after the test period)
stool diary
lifestyle habit questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050161
