UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation test of Intestine regulating effects by ingesting test foods
Acronym	A confirmation test of Intestine regulating effects by ingesting test foods
Scientific Title	A confirmation test of Intestine regulating effects by ingesting test foods
Scientific Title:Acronym	A confirmation test of Intestine regulating effects by ingesting test foods
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is a confirmation of bowel control effects for subjects who tend loose stool by ingesting test foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	* Defecation situation (number of defecation, days of defecation, Bristol Stool Scale score) * Intestinal microbiota (T-RFLP method)
Key secondary outcomes	* Defecation situations (odor of stool, color of stool, exhilaration of defecation, abdominal symptoms) * GSRS questionnaire * Fecal organic acids * Fecal ammonia * Fecal decay products * Fecal properties (pH, water contents)

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	Ingesting one capsule of test food a day for four weeks.
Interventions/Control_2	Ingesting one capsule of control food a day for four 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) Males and females of Japanese aged 20 to 65 years old. (2) Subjects who have troubles because of loose stool. (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 are given continuous treatment by taking medicines. (2) Subjects who use medicines, food for specified health use, functional foods, health foods and supplements more than 3 days a week, those possibly have improving effect of defecation and/or loose stool. (3) Subjects who eat food products containing relatively large amount of yogurt, lactic bacteria beverages and dietary fiber more than 3 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) containing history of surgical operations. (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 (especially to milk and/or to shellfish). (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) Subjects 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 month 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	56

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ikemoto
Organization	NISSHIN PHARMA INC.
Division name	HEALTH CARE RESEARCH CENTER
Zip code	356-8511
Address	5-3-1, Tsurugaoka, Fujimino-city, Saitama, 356-8511, Japan
TEL	049-267-3940
Email	ikemoto.hiroyuki@nisshin.com

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda 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	NISSHIN PHARMA 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 Sanwauchikanda 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 17 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 01 Month 20 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 17 Day
Last follow-up date	2020 Year 04 Month 23 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 13 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045005