UMIN-CTR Clinical Trial

Basic information
Public title	Study on indigenous microbiota using next-generation sequencer
Acronym	Study on indigenous microbiota using next-generation sequencer
Scientific Title	Study on indigenous microbiota using next-generation sequencer
Scientific Title:Acronym	Study on indigenous microbiota using next-generation sequencer
Region	Japan

Condition
Condition	Nothing in particular.
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of the resident microbiota on the severity of mental and physical conditions including malnutrition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dynamics of resident microbiota in food intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Fermented food
Interventions/Control_2	Non-fermented food
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Those who have obtained consent to the purpose of the research
Key exclusion criteria	1. Patients with terminal cancer who may not be expected to be discharged 2. Other cases judged by the representative to be incompatible for conducting this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Irie
Organization	Okayama Prefectural University
Division name	Department of Nutrition Sciences
Zip code	719-1197
Address	111 Kuboki, Soja-city, Okayama
TEL	0866942111
Email	yirie@fhw.oka-pu.ac.jp

Public contact
Name of contact person	1st name Rikako Middle name Last name Inoue
Organization	Okayama Prefectural University
Division name	Department of Nutrition Sciences
Zip code	719-1197
Address	111 Kuboki, Soja-city, Okayama
TEL	0866942111
Homepage URL
Email	rinoue@fhw.oka-pu.ac.jp

Sponsor
Institute	Okayama Prefectural University
Institute
Department

Funding Source
Organization	Okayama Prefectural University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama Prefectural University
Address	111 Kuboki, Soja-city, Okayama
Tel	0866-94-2111
Email	rinoue@fhw.oka-pu.ac.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 01 Month 15 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	200
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	No longer recruiting
Date of protocol fixation	2019 Year 01 Month 08 Day
Date of IRB	2019 Year 01 Month 20 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 15 Day
Last modified on	2021 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046613