UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036711
Receipt number R000041800
Scientific Title Observational study of intestinal environment (SWE-2019-01-HBLACT)
Date of disclosure of the study information 2019/06/02
Last modified on 2021/11/18 11:17:55

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Basic information

Public title

Observational study of intestinal environment (SWE-2019-01-HBLACT)

Acronym

Observational study of intestinal environment

Scientific Title

Observational study of intestinal environment (SWE-2019-01-HBLACT)

Scientific Title:Acronym

Observational study of intestinal environment

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To exploratory survey of intestinal environment in healthy subjects.

Basic objectives2

Others

Basic objectives -Others

To measure the indicators of intestinal environment.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Intestinal function

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Male and Female whose age are 20 <= years old <65.
(2) Subjects who can visit hospital on designated day.
(3) Subjects who are able to submit the written informed consents.

Key exclusion criteria

(1) Subjects who are with treatment.
(2) Subjects who constantly use drug medicine
(3) Subjects who are with history of gastrointestinal surgery.
(4) Subjects who are attending other studies or attended other studies within the past 4 weeks.
(5) Female in pregnancy, lactation and scheduled pregnancy period.
(6) Subjects who are;
a) With present heart disorder, liver disorder, kidney disorder or gastrointestinal tract disorder.
b) With history of cardiac disorder or gastrointestinal tract disorder.
c) With diabetes mellitus, or
(7) Subjects who are not negative by virus immune serology test result at the time of screening.
(8) Subjects who are deemed to be unsuitable by the investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Izumo

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute for Health Care Science

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0630

Email

Takayuki_Izumo@suntory.co.jp


Public contact

Name of contact person

1st name Ken-ichi
Middle name
Last name Wakabayashi

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute for Health Care Science

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0599

Homepage URL


Email

Kenichi_Wakabayashi@suntory.co.jp


Sponsor or person

Institute

SUNTORY WELLNESS LIMITED

Institute

Department

Personal name



Funding Source

Organization

SUNTORY WELLNESS LIMITED

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Miyawaki Orthopedic Clinic Institutional Review Board

Address

3-1-6 Ariakecho, Eniwa City, Hokkaido

Tel

0123-33-4026

Email

d-kameda@mediffom.co.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

2019 Year 06 Month 02 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

2019 Year 05 Month 09 Day

Date of IRB

2019 Year 04 Month 22 Day

Anticipated trial start date

2019 Year 06 Month 03 Day

Last follow-up date

2019 Year 07 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Intestinal environment in healthy subjects


Management information

Registered date

2019 Year 05 Month 10 Day

Last modified on

2021 Year 11 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name