UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method
Title of the study (Brief title)	Microbiota analysis by ERBI
Region	Japan

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

Objectives
Narrative objectives1	Analysis of intestinal metabolite and microbiota by endoscopic retrograde bowel insertion method
Basic objectives2	Others
Basic objectives -Others	Sequencial measurement of colony forming units and metabolite of lactic acid bacteria at terminal ileum after ingestion of a fermented milk drink
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Colony forming units by culture method
Key secondary outcomes	FISH analysis, organic acid concentration, DNA microarray

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A subject takes one bottle of fermented milk drink. It takes less than 9 hours.
Interventions/Control_2	A subject takes one bottle of placebo drink. It takes less than 9 hours.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Subject with gastrointestinal disease
Target sample size	20

Research contact person
Name of lead principal investigator	Shinsaku Fukuda
Organization	Hirosaki University Graduate School of Medicine
Division name	Gastroenterologyand Hematology
Address	5 Zaifu-cho, Hirosaki
TEL	0172-39-5053
Email	sfukuda@hirosaki-u.ac.jp

Public contact
Name of contact person	Shinsaku Fukuda
Organization	Hirosaki University Graduate School of Medicine
Division name	Gastroenterologyand Hematology
Address	5 Zaifu-cho, Hirosaki
TEL	0172-39-5053
Homepage URL
Email	sfukuda@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	弘前大学大学院医学研究科/ Hirosaki University Graduate School of Medicine

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 03 Day
Anticipated trial start date	2015 Year 07 Month 10 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete	2016 Year 04 Month 30 Day
Date analysis concluded	2016 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 30 Day
Last modified on	2017 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020997