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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029224
Receipt No. R000033264
Scientific Title Effects of a Test Food for Defecation Improvement and Intestinal Flora
Date of disclosure of the study information 2017/09/21
Last modified on 2018/03/23

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Basic information
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
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization TAKARA BIO INC.
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
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 09 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 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
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033264

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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