UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044252 |
|---|---|
| Receipt number | R000050539 |
| Scientific Title | A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarten |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/05/25 09:02:10 |
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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
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
m-takahashi@bfsci.co.jp
Sponsor or person
Institute
Center for Preventive Medical Sciences, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050539
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
