UMIN-CTR Clinical Trial

Public title

Effects of a Test Food for Defecation Improvement and Intestinal Flora

Acronym

Effects of a Test Food for Defecation Improvement and Intestinal Flora

Scientific Title

Effects of a Test Food for Defecation Improvement and Intestinal Flora

Scientific Title:Acronym

Effects of a Test Food for Defecation Improvement and Intestinal Flora

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate effects of a test food for defecation improvement and intestinal flora.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes for evaluating defecation and intestinal flora (The Japanese Version of the Constipation Assessment Scale [middle term] [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], Bristol stool scale [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], fecal examination [analysis of intestinal flora, short-chain fatty acid, pH, putrefaction products, IgA] [[first observation: Week 0, 2, 4; second observation: Week 0, 2, 4])

Key secondary outcomes

*Secondary outcome
[1]Bowel diary (from the first day of ingestion of a test material to the last day of the test)

*Safety evaluation
[1]Blood pressure, pulsation (Screening, First observation: Week 4, Second observation: Week 4)
[2]Weight, body fat percentage, BMI (Screening, First observation: Week 4, Second observation: Week 4)
[3]Doctor's questions (Screening, First observation: Week 4, Second observation: Week 4)
[4]Subject's diary(from the first day of ingestion of a test material to the last day of the test)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

[1]Oral ingestion of the test food (2 tablets once a day for 4 weeks)
[2]Washout (4 week)
[3]Oral ingestion of the placebo food (2 tablets once a day for 4 weeks)

Interventions/Control_2

[1]Oral ingestion of the Placebo food (2 tablets once a day for 4 weeks)
[2]Washout (4 week)
[3]Oral ingestion of the test food (2 tablets once a day for 4 weeks)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Female

Key inclusion criteria

[1]Japanese females aged 40-60 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with a tendency for constipation (at 3-4 times of defecation per week).
[4]Individuals whose written informed consent has been obtained.
[5]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals who have a habit of intaking a food containing lactic acid bacteria powder over 4 times per week.
[2]Individuals using medical products.
[3]Individuals who have a habit of using or applying a drug.
[4]Individuals who intake laxatives, antiflatulent, or supplements aiming to improve bowel movements (ex. indigestible dextrin, oligosaccharide, dietary fiber-rich foods).
[5]Individuals whose dietary pattern is unstable.
[6]Individuals who take medicine in the past 1 month to remedy disease (except of temporal taking medicine for headache or cold).
[7]Individuals who intook antibiotics in the past 1 month.
[8]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
[9]Individuals who are a patient or have a history of or endocrine disease.
[10]Individuals whose BMI is over 25 kg/m2.
[11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[12]Individuals who are a smoker.
[13]Individuals with serious anemia.
[14]Individuals who are sensitive to test product or other foods, and medical products.
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[16]Individuals whose life style will be changed during the test period.
[17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[18]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization.
[19]Individuals who are or whose family is engaged in healthy or functional foods.
[20]Individuals judged inappropriate for the study by the principal.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Head

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-5405-1059

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

TAKARA BIO INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

25

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

21

Day

Last modified on

2018

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033264