UMIN-CTR Clinical Trial

Basic information
Public title	Verification of efficacy of intestinal environment improvement effect by ingestion of health food
Acronym	NI intestinal environment study
Scientific Title	Verification of efficacy of intestinal environment improvement effect by ingestion of health food: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym	Verification of efficacy of intestinal environment improvement effect by ingestion of health food
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Evaluate the effects of health food intake on the intestinal environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fecal examination
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	Take the test article for 12 weeks
Interventions/Control_2	Take the placebo for 12 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	25 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Subjects with BMI of 20 or more and less than 30 2.Subjects who defecate less than 6 times a week
Key exclusion criteria	1. Subjects with food allergies 2. Subjects who are pregnant or lactating 3. Subjects who consume medicinal product which may influence the outcome of the study 4.Subjects who consume food which may influence the outcome of the study 5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Masatomo Middle name Last name Najima
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Email	info@yakujihou.org

Public contact
Name of contact person	1st name Takeshi Middle name Last name Kaneko
Organization	Japan Clinical Trial Association
Division name	N.A.
Zip code	1600022
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

Funding Source
Organization	ORTHO Corporation
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 Pharmaceutical Law Wisdoms
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel	0364574911
Email	master@yakujihou.net

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 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.shinryo-to-shinyaku.com/db/pdf/sin_0059_01_0017.pdf
Number of participants that the trial has enrolled	31
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	2021 Year 01 Month 05 Day
Date of IRB	2021 Year 03 Month 01 Day
Anticipated trial start date	2021 Year 03 Month 18 Day
Last follow-up date	2021 Year 06 Month 17 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 03 Month 11 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049778