UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043732 |
|---|---|
| Receipt number | 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 | 2023/06/30 10:56:21 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Metabologenomics, Inc.
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049935
