UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023278
Receipt number R000026826
Scientific Title Effect confirmation test on the intestinal flora of the "Super Orient 108 " plant fermented food
Date of disclosure of the study information 2016/07/21
Last modified on 2016/07/21 16:35:11

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Basic information

Public title


Effect confirmation test on the intestinal flora of the "Super Orient 108 " plant fermented food

Acronym


Effect confirmation test on the intestinal flora of the "Super Orient 108 " plant fermented food

Scientific Title


Effect confirmation test on the intestinal flora of the "Super Orient 108 " plant fermented food

Scientific Title:Acronym


Effect confirmation test on the intestinal flora of the "Super Orient 108 " plant fermented food

Region

Japan


Condition

Condition

Relief of constipation

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To observe the elimination of the dynamics and the constipation of the intestinal bacteria .

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reveal the dynamics of the intestinal bacterial flora in the Super Orient 108 in comparison with similar products .Intake period is eight weeks , intake of 2g per day

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

8 -week intake of "Super Orient 108 " plant fermented food daily intake 2g.

Interventions/Control_2

Placebo , intake in the same way those less effective in a similar fermented food .

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1 , there is no serious disease .
2 , not taking supplements to improve the bowel movement .
3 , it is possible to maintain the day-to-day life .
4 , who was down in the doctor's permission

Key exclusion criteria

1 , a person with a serious disease
2 , a person with a food allergy
3 , pregnant women , breast-feeding women
4 , those who do not down the permission of the doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Tnaka

Organization

Kagawa Nutrition University

Division name

Nutrition Clinic

Zip code


Address

3-24-3 Komagome,Toshima,Tokyo,

TEL

03-3918-6181

Email

clinic@eiyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Kamachi

Organization

Kagawa Nutrition University

Division name

Nutrition Clinic

Zip code


Address

3-24-3 Komagome,Toshima,Tokyo,

TEL

03-3918-6181

Homepage URL


Email

clinic@eiyo.ac.jp


Sponsor or person

Institute

Kagawa Nutrition University

Institute

Department

Personal name



Funding Source

Organization

International Foods Co., Ltd.

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

Kagawa Nutrition University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 07 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

"Super Orient 108 " plant fermented food was able to diversity of the intestinal flora to confirm significantly compared to similar placebo food . It was suggested that effective for the prevention of lifestyle-related diseases by increased diversity .

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

2015 Year 07 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date

2016 Year 01 Month 31 Day

Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 21 Day

Last modified on

2016 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name