UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027857
Receipt number R000031918
Scientific Title Assessment of safety and effective dose of a food thought to improve the intestinal environment.
Date of disclosure of the study information 2017/06/21
Last modified on 2018/01/02 13:24:39

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Basic information

Public title

Assessment of safety and effective dose of a food thought to improve the intestinal environment.

Acronym

Safety of a food thought to improve the intestinal environment.

Scientific Title

Assessment of safety and effective dose of a food thought to improve the intestinal environment.

Scientific Title:Acronym

Safety of a food thought to improve the intestinal environment.

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the safety of daily intake of a food thought to improve the intestinal environment and determine the effective dose.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Interview with a doctor

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Male subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.

Interventions/Control_2

Female subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.

Interventions/Control_3

Male subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.

Interventions/Control_4

Female subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Those who can understand the purpose and contents of this study and agree by letter to participate.
2. Those who have been diagnosed with a tendency to constipation after responding to a questionnaire.

Key exclusion criteria

1. Pregnant women, breast feeding mothers
2. Those who are taking medication for a disease of the digestive organs (including constipation symptoms), that affects gastrointestinal function.
3. Those who have a disease.
4. Those who have an allergy to fruit.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Shunji Mizobuchi

Organization

Kochi Medical School, Kochi University

Division name

Clinical nursing

Zip code


Address

Kohasu, Oko-cho, Nankoku-city, Kochi, Japan

TEL

088-866-5811

Email

mizoshun@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunji Mizobuchi

Organization

Kochi Medical School, Kochi University

Division name

Clinical nursing

Zip code


Address

Kohasu, Oko-cho, Nankoku-city, Kochi, Japan

TEL

088-880-2564

Homepage URL


Email

mizoshun@kochi-u.ac.jp


Sponsor or person

Institute

Kochi University

Institute

Department

Personal name



Funding Source

Organization

Public Interest Incorporated Foundation
KOCHI INDUSTRIAL PROMOTION CENTER

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Umajimura agricultural cooperative
MUSE Co.,Ltd.

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

高知大学医学部(高知県)、高知大学医学部附属病院(高知県)、医療法人 仁泉会 朝倉病院(高知県)、馬路村立馬路診療所(高知県)


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 21 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

2017 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 21 Day

Last follow-up date

2017 Year 11 Month 17 Day

Date of closure to data entry

2017 Year 11 Month 17 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 21 Day

Last modified on

2018 Year 01 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name