UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031782 |
|---|---|
| Receipt number | R000035927 |
| Scientific Title | Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2024/09/22 17:23:35 |
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Basic information
Public title
Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study
Acronym
Efficacy of yogurt to intestinal flora in Japanese healthy adults
Scientific Title
Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study
Scientific Title:Acronym
Efficacy of yogurt to intestinal flora in Japanese healthy adults
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of yogurt on the intestinal microbiome in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of intestinal microbiome before and after taking yogurt
Key secondary outcomes
The change of bowel habits before and after taking yogurt
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
150 ml of yogurt (Yasuda Yogurt) is taken daily for 14 days. After 14-day wash out period, 300 ml of yogurt (Yasuda Yogurt) is taken daily for 14 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
Subjects who meet any of the following conditions will be excluded.
1) Subjects who have a history of taking probiotics.
2) Subjects who have a history of a malignant disease.
3) Subjects who have lactose intolerance.
4) Subjects who have a history of a severe systemic disease.
5) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Wakai |
| Middle name | |
| Last name | Toshifumi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2228
wakait@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tajima |
| Middle name | |
| Last name | Yosuke |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2228
Homepage URL
y-tajima@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Yasuda Yogurt Co., Ltd
Bourbon Co., Ltd.
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
Tel
025-227-2565
ethics@adm.niigata-u.ac.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
| 2018 | Year | 03 | Month | 20 | 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
10
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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035927
