UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial on improving children's QOL through the intestinal environment
Acronym	Clinical trial on improving children's QOL through the intestinal environment
Scientific Title	Clinical trial on improving children's QOL through the intestinal environment
Scientific Title:Acronym	Clinical trial on improving children's QOL through the intestinal environment
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the effect of improving children's QOL through the intestinal environment by ingesting kestose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	KINDL score
Key secondary outcomes	Average number of bowel movements per week (according to a questionnaire) Fecal properties (by Bristol stool scale / questionnaire) Changes in the intestinal flora in feces Changes in the copy number of intestinal bacteria in feces Changes in short-chain fatty acids in feces

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 2 g of kestose daily for 12 weeks
Interventions/Control_2	Intake 2 g of maltose daily 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	3 years-old <=
Age-upper limit	7 years-old >
Gender	Male and Female
Key inclusion criteria	1.Persons whose substitute (guardian) have consented to participate in the trial 2.Japanese who are 3 years old or older and less than 7 years old and first or second year of kindergarten at the time of obtaining consent from their guardian
Key exclusion criteria	1.Persons who have a chronic illness and plan to start, end or change drug treatment during the study period, or those who have a history of serious illness 2.Persons who are allergic to test foods 3.Persons who plan to start or end new intake of probiotics / prebiotics or foods during the study period 4.Persons who used antibacterial drugs within 2 months at the start of the test 5.Persons who are judged to be ineligible by the judgment of the principal investigator or the research coordinator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Yamashita
Organization	School Corporation Ohkagakuen
Division name	Nagoya College
Zip code	470-1193
Address	48 Takeji, Sakae-cho, Toyoake-shi, Aichi, JAPAN
TEL	0562-97-1306
Email	yamashita@nagoyacollege.ac.jp

Public contact
Name of contact person	1st name Mayuko Middle name Last name Takahashi
Organization	B food science Co., Ltd.
Division name	Research Unit Research and Development Center
Zip code	478-0046
Address	24-12, Kitahama-machi, Chita-shi, Aichi, JAPAN
TEL	0562-55-1734
Homepage URL
Email	m-takahashi@bfsci.co.jp

Sponsor
Institute	School Corporation Ohkagakuen
Institute
Department

Funding Source
Organization	B food science 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	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@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	2021 Year 03 Month 31 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	40
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 23 Day
Date of IRB	2021 Year 03 Month 23 Day
Anticipated trial start date	2021 Year 05 Month 24 Day
Last follow-up date	2021 Year 09 Month 20 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 31 Day
Last modified on	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049991