UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation study of bowel control effect by consumption of the test food
Acronym	A confirmation study of bowel control effect by consumption of the test food
Scientific Title	A confirmation study of bowel control effect by consumption of the test food
Scientific Title:Acronym	A confirmation study of bowel control effect by consumption of the test food
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is confirmation of bowel control effect for constipation tendency subjects by consumption of the test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation status (defecation frequency, defecation days, Bristol Stool Sclae)
Key secondary outcomes	*Defecation status (smell of stool, color of stool, volume of stool, exhilaration by defecation, abdominal symptoms) * Analysis of organic acids content in stool * Stool properties (pH of stool, water content of stool) * Analysis of stool ammonia * Intestinal microbiota (Analysis by sequencing of amplicons) * Incidence of adverse events and of side effects

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake one capsule of the test food a day for two weeks
Interventions/Control_2	Intake one capsule of the control food a day for two 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 males and females aged over 20 to under 65 when informed consent. 2)Subjects who are defecated tendency (their defecation frequency are 3 to 5 times a week) 3)Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	1) Subjects who constantly eat seaweeds like simmered laver in sweetened soy sauce etc., or subjects who can't restrict eat them during test period. 2) Subjects who are given continuous treatment by taking medicines. 3) Subjects who intaking Food for Specified Health Uses (FOSHU), food with function claims and/or health food, those having possibility of defecation improvement or soft stool improvement, more than three days a week. 4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 6) Subjects who excessive alcohol intake. 7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 8) Subjects who have previous medical history of drug and/or food allergy. 9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 11) Males who donated over 400mL blood and/or blood components within the last three months to the current study. 12) Females who donated over 400mL blood and/or blood components within the last four months to the current study. 13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 15) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Terasawa
Organization	KONAN CHEMICAL MANUFACTURING CO., LTD.
Division name	Healthcare Business Dept.
Zip code	510-0103
Address	1515 Kitagomizuka, kusu-cho, Yokkaichi-city, Mie-Perf., 510-0103, Japan
TEL	059-397-2612
Email	terasawa@konanchemical.co.jp

Public contact
Name of contact person	1st name Mitsuhiro Middle name Last name Fujimoto
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda 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	KONAN CHEMICAL MANUFACTURING 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 Sanwauchikannda Building, 3-3-5 Uchikanda 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 02 Month 28 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 02 Month 25 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 02 Month 28 Day
Last follow-up date	2020 Year 04 Month 17 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 02 Month 25 Day
Last modified on	2021 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045150