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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037061
Receipt No. R000042227
Scientific Title Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Date of disclosure of the study information 2019/06/13
Last modified on 2019/12/12

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Basic information
Public title Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Acronym Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Scientific Title Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Scientific Title:Acronym Study for influence of long-term intake of pineapple on improvement in intestinal environment for children
Region
Japan

Condition
Condition Healthy Children
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify effect of long-term intake intervention of pineapple for children on intestinal environment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal bacterial flora before and after intake of 4 weeks
Key secondary outcomes Questionnaire on defecation
Urine test (Indoxyl sulfate)
before and after intake of 4 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake 100g of pineapple per day.
Interventions/Control_2 none
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
6 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria 1.Those who receive written consent from parents who fully understand the purpose and contents of this study
2.Healthy Japanese those who are 6 to 12 years old at the time of consent acquisition
3.Those who defecate 2 to 4 times a week
Key exclusion criteria 1.Those who have a chronic disease and are undergoing medication, those with a serious disease history
2.Those who are allergic to the test food
3.Those who have never taken a pineapple in the past
4.Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent
5.Those who are judged ineligible at the examination doctor and research leader
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 1050004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email masudat@hc-sys.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd
Division name Research and Development Department
Zip code 1050004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email masudat@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization SOLROS Co., Ltd.
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 Healthcare Systems Ethics Committee
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email kakehashi@hc-sys.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
2019 Year 06 Month 13 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
2019 Year 06 Month 13 Day
Date of IRB
2019 Year 06 Month 13 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 13 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042227

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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