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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027688
Receipt No. 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 2018/06/26

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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
12g/day for 2 weeks
Interventions/Control_2 lactic acid bacteria beverage supplement 100ml/day for 2 weeks
Interventions/Control_3 yoghurt supplement 150g/day for 2weeks
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
Last name of lead principal investigator
1st name
Middle name
Last name Akira Takahashi
Organization Tokushima University
Division name Division of Preventive Enviroment and Nutrition
Zip code
Address 3-18-15 Kumamoto, Tokushima
TEL 088-633-9428
Email akiratak@tokushima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akira Takahashi
Organization Tokushima University
Division name Division of Preventive Enviroment and Nutrition
Zip code
Address 3-18-15 Kumamoto, Tokushima
TEL 088-633-9428
Homepage URL
Email akiratak@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization TANITA
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
Address
Tel
Email

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
2018 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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