UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047411