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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043732
Receipt No. R000049935
Scientific Title Additional analysis of the intestinal environment on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption
Date of disclosure of the study information 2021/03/26
Last modified on 2021/03/25

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Basic information
Public title Additional analysis of the intestinal environment on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption
Acronym Additional analysis of the intestinal environment on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption
Scientific Title Additional analysis of the intestinal environment on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption
Scientific Title:Acronym Additional analysis of the intestinal environment on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption
Region
Japan

Condition
Condition Healthy female adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate the fecal IgA level on the previous study: An evaluation test for alteration of the intestinal environment by test food consumption(UMIN000028734).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total IgA amount in fecal samples
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
59 years-old >=
Gender Female
Key inclusion criteria Subjects who took part in our previous trial: An evaluation test for alteration of the intestinal environment by test food consumption (UMIN000028734)
Key exclusion criteria Subjects who have been excluded from the data analysis on our previous trial: An evaluation test for alteration of the intestinal environment by test food consumption (UMIN000028734)
Target sample size

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Fukuda
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code 997-0052
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email research@metagen.co.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ichinohe
Organization CPCC Company Limited
Division name Clinical Planning Department
Zip code 101-0047
Address 4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo,101-0047, Japan
TEL +81-3-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute Metabologenomics, Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Q'SAI CO., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo,101-0047, Japan
Tel +81-3-5297-5548
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
2021 Year 03 Month 26 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 19 Day
Date of IRB
2021 Year 03 Month 19 Day
Anticipated trial start date
2021 Year 03 Month 26 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluating the fecal IgA level on the previous study: An evaluation test for alteration of the intestinal environment by test-food consumption (UMIN000028734).
There are no additional interventions and sample collections.

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049935

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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