UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027688 |
|---|---|
| Receipt number | R000031716 |
| Scientific Title | Validation study of non-invasive signal analysis for presumption of balance of an intestinal flora by the human study |
| Date of disclosure of the study information | 2017/06/08 |
| Last modified on | 2021/11/09 11:48:22 |
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Basic information
Public title
Validation study of non-invasive signal analysis for presumption of balance of an intestinal flora by the human study
Acronym
Validation study of non-invasive signal analysis for an intestinal flora
Scientific Title
Validation study of non-invasive signal analysis for presumption of balance of an intestinal flora by the human study
Scientific Title:Acronym
Validation study of non-invasive signal analysis for an intestinal flora
Region
| Japan |
Condition
Condition
Enteropathy
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the sound characteristic of the bowels peristalsis sound
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
bowels peristalsis sound
Key secondary outcomes
bacterial flora in feces
low molecular metabolic product in feces
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Lactobacillus preparation supplement
2g/day for 4 weeks
Interventions/Control_2
lactic acid bacteria beverage supplement 100ml/day for 4 weeks
Interventions/Control_3
yoghurt supplement 150g/day for 4weeks
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
| 10 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
male and female
10-99 years old
Key exclusion criteria
milk allergy
food allergy
infectious gastroenteritis
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takahashi |
Organization
Tokushima University
Division name
Division of Preventive Enviroment and Nutrition
Zip code
770-0042
Address
3-18-15 Kumamoto, Tokushima
TEL
088-633-9428
akiratak@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Takahashi |
Organization
Tokushima University
Division name
Division of Preventive Enviroment and Nutrition
Zip code
770-0042
Address
3-18-15 Kumamoto, Tokushima
TEL
088-633-9428
Homepage URL
akiratak@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
TANITA(Until May 2020)
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima 770-8503, Japan
Tel
088-633-9294
brinshoshienk@tokushima-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
| 2017 | Year | 06 | Month | 08 | 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
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031716
