UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052099 |
|---|---|
| Receipt number | R000059461 |
| Scientific Title | Trial on the effect of kestose on the gut microbiota of pregnant women and newborns. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2023/09/04 13:16:02 |
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Basic information
Public title
Trial on the effect of kestose on the gut microbiota of pregnant women and newborns.
Acronym
Trial on the effect of kestose on the gut microbiota
Scientific Title
Trial on the effect of kestose on the gut microbiota of pregnant women and newborns.
Scientific Title:Acronym
Trial on the effect of kestose on the gut microbiota
Region
| Japan |
Condition
Condition
Pregnant women and their newborns
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of fructooligosaccharides and 1-kestose in equal amounts on the gut microbiota of pregnant women and newborns.
Basic objectives2
Others
Basic objectives -Others
The effect on gut microbial composition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composition of the gut microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Kestose
Interventions/Control_2
Fructooligosaccharide
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Those who have consented to participate in the trial
2) Aged between 20 and 40 years at
3) Pregnant women with a gestational age of 26 weeks or less
4) Healthy newborns for whom stool samples can be collected
Key exclusion criteria
1) Those with a serious chronic disease not related to pregnancy that requires medication or hospital treatment
2) Those taking probiotics/prebiotics during the study period (excluding those generally treated as food, such as yoghurt).
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 | 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
Homepage URL
shimojo@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Masuda Obstetrics And Gynecology
Clinical and Translational Research Center, Keio University Hospital
Name of secondary funder(s)
B food science Co., Ltd.
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
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
| 2024 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059461
| Research Plan | |
|---|---|
| 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 |
