UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052935 |
|---|---|
| Receipt number | R000060398 |
| Scientific Title | The effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/11/28 19:30:48 |
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Basic information
Public title
The effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota
Acronym
The effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota
Scientific Title
The effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota
Scientific Title:Acronym
The effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the co-ingestion of probiotics and poly- and oligo-saccharides on gut microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abundance of the probiotics in fecal samples
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. After the 1-week observation period, participants will consume both probiotics X for 1 week, followed by a pause for 1 week.
2. Participants will consume both probiotics X and food A for 1 week, and food A for 1 week, followed by a pause for 1 week.
3. Change food A to food B and repeat the above schedule.
4. Change food B to food C and repeat the above schedule.
5. During the above periods, all participants are to avoid binge eating and drinking, and consumption of foods that contain probiotic products, prebiotic products, foods A, B, C and similar ingredients.
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
Healthy adults
Key exclusion criteria
1. Subjects who are pregnant or possibly pregnant.
2. Subjects regularly taking laxatives or antibiotics
3. Subjects judged as unsuitable for the study participant
4. Subjects participating or willing to participate in other studies with food intervention
5. Subjects judged as unsuitable for the study participant by principal investigator from other reasons
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Matsuki |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo
TEL
042-577-8922
takahiro-matsuki@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
5-11 Izumi, Kunitachi, Tokyo
TEL
042-577-8922
Homepage URL
yuki-saito@yakult.co.jp
Sponsor or person
Institute
Yakult Central Institute
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
cpcc-contact@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
| 2023 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060398
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
