UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029224 |
|---|---|
| Receipt number | 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 09:13:46 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033264
