UMIN-CTR Clinical Trial

Basic information
Public title	A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarten
Acronym	Defecation improvement test with kestose
Scientific Title	A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarten
Scientific Title:Acronym	Defecation improvement test with kestose
Region	Japan

Condition
Condition	constipation
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effect of 1-kestose intake on the defecation habits of kindergarten children who are prone to constipation, and to investigate the effect on the intestinal flora.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Changes in the number of defecation days per week (according to the questionnaire)
Key secondary outcomes	Average number of defecation per week (according to a questionnaire) Fecal properties (by Bristol stool property scale / questionnaire) Changes in the intestinal flora in feces Changes in the number of copies of intestinal bacteria in feces Changes in short-chain fatty acids in feces Incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1-kestose (3g/day,2months)
Interventions/Control_2	Maltose (3g/day,2months)
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	6 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who have consented to participate in the trial from their substitute (guardian) 2) Those who defecate less than 4 times a week 3) Those whose age at the time of obtaining consent by their parents is 3 to 6 years old 4) Those who are certified as No. 1 childcare certification
Key exclusion criteria	1) Those who have a chronic illness and plan to start, end or change drug treatment during the trial period, or those who have a history of serious illness 2) Those who are allergic to test foods 3) Those who plan to start or end the intake of probiotics / prebiotics preparations or foods during the trial period.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Shimojo
Organization	Chiba University
Division name	Center for Preventive Medical Sciences
Zip code	263-8522
Address	1-33,Yayoicho,Inage-ku,Chiba city,Chiba,Japan
TEL	043-290-3878
Email	shimojo@faculty.chiba-u.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 & Development center
Zip code	478-0046
Address	24-12 kitahama-machi, Chita city, Aichi, Japan
TEL	0562-55-1629
Homepage URL
Email	m-takahashi@bfsci.co.jp

Sponsor
Institute	Center for Preventive Medical Sciences, Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chiba University Hospital Nouvelle Place Inc.
Name of secondary funder(s)	B food science Co., Ltd.

IRB Contact (For public release)
Organization	Chiba University Graduate School of Medicine Research Ethics Committee
Address	1-8-1 Inohana Chiba, Chuo-ku, Japan
Tel	043-226-2501
Email	inohana-soumu1@chiba-u.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	千葉敬愛短期大学附属幼稚園（千葉県） 千葉大学教育学部附属幼稚園（千葉県）

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 01 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	23
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	No longer recruiting
Date of protocol fixation	2021 Year 04 Month 30 Day
Date of IRB	2021 Year 04 Month 30 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 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 05 Month 19 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050539