UMIN-CTR Clinical Trial

Basic information
Public title	A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Acronym	A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Scientific Title	A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Scientific Title:Acronym	A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Region	Japan

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

Objectives
Narrative objectives1	To verify the intestinal regulation effect by consumption of the food containing lactic acid bacteria for four weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Defecation frequency *Volume of stool
Key secondary outcomes	*Property of stool *Color of stool *Gut microbiota *Spoilage products in stool *Short-chain fatty acids in stool

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	Prevention
Type of intervention	Food
Interventions/Control_1	Consume two tablets of test food with water a day for 4 weeks - Washout 4 weeks - Consume two tablets of placebo food with water a day for 4 weeks
Interventions/Control_2	Consume two tablets of placebo food with water a day for 4 weeks - Washout 4 weeks - Consume two tablets of test food with water a day for 4 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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged 20 to 59 years old. (2) Subjects who defecate less than and equal to 5 times in a week. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1) Subjects who didn't undergo abdominal surgical operation within 6 month before the test. (2) Subjects who didn't take antibiotics within 1 month before the test. (3) Subjects who have allergy to test food. (4) Subjects who are heavy drinkers of alcohol. (5) Subjects who plan big change of lifestyle during the test. (6) Subjects with tendency of chronic diarrhea. (7) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver functions, kidney functions, cardiovascular system and digestive systems. (8) Subjects who suspected serious infectious disease. (9) Females who are pregnant (including the possibility of pregnancy) or are lactating. (10) Subjects who have participated the other clinical test within 1 month before the test. (11) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination. (12) Subjects who have a plan to start consuming medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) during examination. (13) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (14) Males who donated over 400mL blood within the last 3 months to the current study. (15) Females who donated over 400mL blood within the last 4 months to the current study. (16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (18) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

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 Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales 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	ICHIBIKI 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 Chusin 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	2020 Year 03 Month 31 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	30
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 07 Month 20 Day
Date of IRB	2018 Year 07 Month 19 Day
Anticipated trial start date	2018 Year 09 Month 05 Day
Last follow-up date	2019 Year 09 Month 30 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 09 Month 03 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=R000038347