UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Acronym	An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Scientific Title	An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Scientific Title:Acronym	An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Region	Japan

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

Objectives
Narrative objectives1	To verify the influence for intestinal environment by consumption of the spore-forming lactic acid bacteria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	*Improvement of bowel movement *Evaluation of intestinal microbiota by 16S metagenomic analysis * Evaluation of intestinal metabolites by metabolome analysis
Key secondary outcomes	* Skin tests * The incidence of adverse events * The incidence of side effects

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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	Take 1 tablet of test food at a time, 3 times a day after every meal, for 28 days -- Washout 4 weeks --Take 1 tablet of placebo at a time, 3 times a day after every meal, for 28 days
Interventions/Control_2	Take 1 tablet of placebo at a time, 3 times a day after every meal, for 28 days -- Washout 4 weeks -- Take 1 tablet of test food at a time, 3 times a day after every meal, for 28 days
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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 30 to 49 years old. (Target half a ratio of men and women) 2) Subjects who defecate 3 to 5 times in a week. 3) Subjects who do not routinely use medicines or the gastrointestinal related health foods during the examination period. 4) 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)Subject who concern difficult to carry out skin test, due to having birthmarks, scratches and a lot of acne on the skin. 2) Subject who have undergone abdominal surgery within 6 months. 3) Subject who took antibiotics within 6 months. 4) Subject who have allergy to the test food. 5) Smoker 6) Subjects whose consort or partner also participates to same clinical test. 7) Subjects who plan big change of lifestyle during test period. 8) Subjects with tendency of chronic diarrhea. 9) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 10) Subjects who suspected chronic or serious infectious disease. 11) Females who are pregnant or are lactating. And/or females who are the possibility of pregnancy. 12) Subjects who have participated in other clinical studies within 3 months. 13) Subjects who routinely use food for specific health use, functional foods and/or health foods. 14) Other subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Katsuhisa Middle name Last name Sakano
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	Metagen, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	DAIICHI SANKYO HEALTHCARE CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin 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	2017 Year 02 Month 24 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	2017 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 23 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030173