UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043790
Receipt No. R000049991
Scientific Title Clinical trial on improving children's QOL through the intestinal environment
Date of disclosure of the study information 2021/03/31
Last modified on 2021/09/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Open public recruiting
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
2021 Year 09 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.