UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043790 |
|---|---|
| Receipt number | 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 | 2022/04/01 16:09:59 |
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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
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
m-takahashi@bfsci.co.jp
Sponsor or person
Institute
School Corporation Ohkagakuen
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049991
