UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050000 |
|---|---|
| Receipt number | R000056951 |
| Scientific Title | Effects of synbiotic yogurt on the intestinal function: An exploratory study |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2024/01/11 09:36:01 |
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Basic information
Public title
Effects of synbiotic yogurt on the intestinal function: An exploratory study
Acronym
Effects of synbiotic yogurt on the intestinal function: An exploratory study
Scientific Title
Effects of synbiotic yogurt on the intestinal function: An exploratory study
Scientific Title:Acronym
Effects of synbiotic yogurt on the intestinal function: An exploratory study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of yogurt containing synbiotics on regulating the intestinal function for subjects with constipation tendency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool frequency, Fecal characteristics, Bowel movements, Abdominal symptoms
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
Intake of synbiotic yogurt 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged 18 years or older and younger than 75 years.
2) Subjects with a tendency for constipation (less than 5 times per week) or subjects who feel constipated themselves.
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 study.
8) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
University of Nagasaki
Division name
Regional Partnership Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
095-813-5216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Imai |
Organization
University of Nagasaki
Division name
Regional Partnership Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
095-813-5500
Homepage URL
kimai@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
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
University of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
Tel
095-813-5216
katanaka@sun.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
| 2023 | Year | 01 | Month | 12 | 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
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 04 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056951
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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