UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029687 |
|---|---|
| Receipt number | R000033658 |
| Scientific Title | Exploratory study for intestinal environment markers. |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2017/11/16 10:47:19 |
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Basic information
Public title
Exploratory study for intestinal environment markers.
Acronym
Exploratory study for intestinal environment markers.
Scientific Title
Exploratory study for intestinal environment markers.
Scientific Title:Acronym
Exploratory study for intestinal environment markers.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search blood markers reflecting intestinal environment
Basic objectives2
Others
Basic objectives -Others
To search blood markers
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between results of existing test and blood protein A levels
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) Subjects aged 20 or more years-old
2) Subjects whose blood protein A is above the lower limit of quantification
3) Subjects who can visit hospital on designated day
4) Subjects giving written informed consent
Key exclusion criteria
1) Subjects whose systolic blood pressure is less than 90mmHg
2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study
4) Males whose blood was collected more than 400 mL within the last three months
5) Females whose blood was collected more than 400 mL within the last four months
6) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added
7) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added
8) Diabetic patients
9) Subjects who have allergic reactions to sugar alcohols
10) Subjects who are on lactose-restricted diet
11) Subjects who have any one of diseases in heart, liver, kidney or gastrointestinal tract
12) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
13) Subjects with a previous history of cardiovascular disease and digestive tract disease
14) Subjects who have allergic reaction to drug medicine
15) Subjects who drink alcohol a lot and smoke a lot
16) Subjects who have an irregular sleep cycle, work shift or work on midnight shift
17) Subjects who constantly use drug medicine affecting the test results
18) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihito Murayama |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0588
Norihito_Murayama@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Wakabayashi |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0599
Homepage URL
Kenichi_Wakabayashi@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福原医院 （北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between results of existing test and blood protein A levels
Management information
Registered date
| 2017 | Year | 10 | Month | 24 | Day |
Last modified on
| 2017 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033658
