UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation test on loose stool and constipation improvement effect by ingesting test foods
Acronym	Confirmation test on loose stool and constipation improvement effect by ingesting test foods
Scientific Title	Confirmation test on loose stool and constipation improvement effect by ingesting test foods
Scientific Title:Acronym	Confirmation test on loose stool and constipation improvement effect 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	To confirm the improving effect on loose stool and constipation by ingesting test foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestine regulating function (Gastrointestinal Symptom Rating Scale, stool frequency, stool days, Bristol Stool Form Scale)
Key secondary outcomes	Defecation status (volume of stool, stool color, odor of stool, refresh feeling of defecation), SF-36 version-2 Incidence rate of side effects and adverse events

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 test food one capsule a day for four weeks. Receive tests before, two weeks after and four weeks after starting test food intake.
Interventions/Control_2	Intake control food one capsule a day for four weeks. Receive tests before, two weeks after and four weeks after starting test food intake.
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 and/or constipation. (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 month to the current study. (12) Females who donated over 400mL blood and/or blood components within the last four month 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 month 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	60

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Sales & Planning Department
Zip code	101-0047
Address	4F Chusin 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	2019 Year 10 Month 14 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	60
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	2018 Year 10 Month 04 Day
Date of IRB	2018 Year 10 Month 04 Day
Anticipated trial start date	2018 Year 10 Month 15 Day
Last follow-up date	2018 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039270