UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051912 |
|---|---|
| Receipt number | R000059027 |
| Scientific Title | An exploratory study on the effect on gut microbiome by taking synbiotic yogurt |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/02/13 09:54:28 |
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Basic information
Public title
An exploratory study on the effect on gut microbiome by taking synbiotic yogurt
Acronym
An exploratory study on the effect on gut microbiome by taking synbiotic yogurt
Scientific Title
An exploratory study on the effect on gut microbiome by taking synbiotic yogurt
Scientific Title:Acronym
An exploratory study on the effect on gut microbiome by taking synbiotic yogurt
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratorily examine the effect on gut microbiome by synbiotic yogurt.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool frequency, Fecal characteristics, Bowel movements, Gut microbiome, Gut metabolites, Questionnaire surveys
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
Take 100g test food daily for 4 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 18 years and 74 years old at the time consent obtained.
Key exclusion criteria
1) Subjects who regularly use drugs that affect bowel movements such as laxatives, medicine for intestinal disorders.
2) Subjects who regularly intake supplements containing Lactic acid bacteria, Bifidobacterium, oligosaccharide, and dietary fiber.
3) Subjects who have disease or serious medical history in liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism, etc.
4) Subjects with medication allergy, food allergy, or serious history of these.
5) Subjects with milk allergy and lactose intolerance.
6) Subjects who are pregnant, under lactation or expecting to be pregnant during this study
7) Subjects who participated in other study within 1 month prior to obtaining informed consent, or those who are going to participate these studies.
8) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata Prefecture 997-0052, Japan
TEL
0235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba, Shinjuku, Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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 | 08 | Month | 16 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 14 | 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 | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059027
| 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 |
