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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name