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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043592
Receipt No. R000049778
Scientific Title Verification of efficacy of intestinal environment improvement effect by ingestion of health food: a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2021/03/18
Last modified on 2021/09/09

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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 23 to 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 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 No longer recruiting
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
2021 Year 09 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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