UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041529 |
|---|---|
| Receipt number | R000047411 |
| Scientific Title | Confirmation test about improvements of intestinal environment and immune function by test-food intake |
| Date of disclosure of the study information | 2021/08/26 |
| Last modified on | 2021/07/20 18:31:32 |
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Basic information
Public title
Confirmation test about improvements of intestinal environment and immune function by test-food intake
Acronym
Confirmation test about improvements of intestinal environment and immune function by test-food intake
Scientific Title
Confirmation test about improvements of intestinal environment and immune function by test-food intake
Scientific Title:Acronym
Confirmation test about improvements of intestinal environment and immune function by test-food intake
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether test-food intakes can improve the conditions of defecation, intestinal flora, and immune function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Bowel movement situation (frequency, number of days, amount, nature)
2. CAS-MT
Key secondary outcomes
1. Amplicon sequence analysis of changes in the behavior of intestinal bacterial flora
2. Bowel movement situation (color, smell, abdominal muscle pressure, feeling of constipation, abdominal pain)
3. NK cell activity
4. Changes in laboratory value
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
Consumption of the test food (1 drop) to the subjects after breakfast (i.e., once a day).
Interventions/Control_2
Consumption of the placebo food (1 drop) to the subjects after breakfast (i.e., once a day).
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64.
(2) Subjects having their defecation within 3~5 times a week.
(3) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects with some kind of medical treatment continuously.
(2) Subjects who have used some kind of medicine that might affect their intestine-regulating and immune functions.
(3) Subjects who have used the following foods that might affect their intestine-regulating and immune functions;
health-specific, functional, supplemental, health foods.
(4) All through this trial, subjects who have any difficulty in refraining from having denying/restricting foods.
(5) Pregnant or possibly pregnant women, or lactating ones.
(6) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(7) Subjects with excessive alcohol intake.
(8) Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work.
(9) Subjects with previous medical history of drug and/or food allergy (especially in a soybean).
(10) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after the current trial.
(11) Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial.
(12) Male subjects who donated over 400 mL of their whole blood within the last three months to the current trial.
(13) Female subjects who donated over 400 mL of their whole blood within the last four months to the current trial.
(14) Male subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(15) Female subjects who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Onodera |
Organization
KOEI SCIENCE LABORATORY Co., Ltd.
Division name
Executive Managing Director
Zip code
351-0115
Address
5-1-25 Niikura, Wako-shi, Saitama 351-0115, Japan
TEL
048-647-334
btob@koei-science.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
KOEI SCIENCE LABORATORY 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
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
| 2021 | Year | 08 | Month | 26 | 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
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047411
