UMIN-CTR Clinical Trial

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