UMIN-CTR Clinical Trial

Basic information
Public title	A Study of the effects of a test-food on gut microenvironment
Acronym	A Study of the effects of a test-food on gut microenvironment
Scientific Title	A Study of the effects of a test-food on gut microenvironment
Scientific Title:Acronym	A Study of the effects of a test-food on gut microenvironment
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to validate some kind of effect by the test-food intakes for two weeks on gut microenvironment and immunity
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestinal flora (next generation-targeted amplicon sequencing analysis)
Key secondary outcomes	1. Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain) 2. In stool: short chain fatty acids, ammonia, spoiled products, pH, water, and IgA 3. In blood: NK-cell activity, highly sensitive CRP, IL-6, and TNF-alpha 4. In saliva: cortisol and alpha-amylase 5. Constipation assessment scale-mid term 6. MOS 36-Item Short-Form Health Survey version2 (acute version)

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	Ingestion of the test food (10 capsules a day) with water/lukewarm water to the subjects for 2 weeks.
Interventions/Control_2	Ingestion of the placebo food (10 capsules a day) with water/lukewarm water to the subjects for 2 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	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, at informed consent. (2) Subjects ranging in defection frequency from not less than three times to less than five times a week. (3) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, yogurts or lactic acid beverages, which might affect the test results (intestinal regulation and immune maintenance). (2) Subjects who have taken affecting medicines (allergic/gut/laxative/antibiotic regulation) except eye/nose drops, within the last month before the hospital visiting (0 W at the first stage). (3) Subjects who will vaccinate within the last three weeks before the hospital visiting (0 W at the first stage) and during this study. (4) Subjects who had undergone appendectomy. (5) Subjects who have received the affecting surgery (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. (6) Subjects who will change their life style and dietary habit during this study. (7) Subjects with extremely irregular dietary habits. (8) Subjects who take excessive alcohol. (9) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (10) Pregnant, possibly pregnant, or lactating women. (11) Subjects having drug and/or food allergy. (12) Subjects who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this study, or will participate in that after giving informed consent to take part in this study. Subjects - - (13) who donated their blood components or blood (0.2 L) within the last month, (14) who donated his blood (0.4 L) within the last 3 months, (15) who donated her blood (0.4 L) within the last 4 months, (16) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (17) being collected in total of her blood (0.8 L) within the last 12 months and in this study - - . (18) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support 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
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning 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	Nisshin Seifun Group 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	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	2022 Year 10 Month 07 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	2021 Year 09 Month 22 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 10 Month 07 Day
Last follow-up date	2021 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	2021 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052016