UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034023 |
|---|---|
| Receipt number | R000038788 |
| Scientific Title | A randomised controlled trial of kestose in growth promotion effect of bifodobacteria and safety in premature neonates |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/03/28 11:33:10 |
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Basic information
Public title
A randomised controlled trial of kestose in growth promotion effect of bifodobacteria and safety in premature neonates
Acronym
Kestose administration trial in neonates
Scientific Title
A randomised controlled trial of kestose in growth promotion effect of bifodobacteria and safety in premature neonates
Scientific Title:Acronym
Kestose administration trial in neonates
Region
| Japan |
Condition
Condition
Growth promotion effect of bifidobacteria
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and analyze differences in the amount of bifidobacteria in feces of low birth weight infants with bifidobacteria plus lactulose or bifidobacteria plus kestose administration
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of bifidobacteria in stool specimens collected at 1, 2, 4 weeks after birth in each group
Key secondary outcomes
1.16S gut microbiome analysis at 1, 2, 4 weeks after birth in each group
2.Measurement of short-chain fatty acids in stool specimens collected at 1, 2, 4 weeks after birth in each group
3.Frequency of defecation (days 0, 7, 14, 21, 28)
4.Difference in time until birth weight restoration in each group.
5.Weight gain rate upto corrected 40th week of gestational age in each group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Both groups are administered from hospitalization until discharge.
<Intervention>
1 packege of Bifidobacterium breve and 0.3 g of crystalline kestose powder and 1.125 ml of water for injection, and then administer 1 ml thereof once a day (the number of bacteria is 500 million).
Interventions/Control_2
Both groups are administered from hospitalization until discharge.
<Control>
1 packege of Bifidobacterium breve and lactulose (Refolos syrup) 0.3 ml and 1 ml water for injection are mixed, 1 ml of which is administered once a day (the number of bacteria is 500 million).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Less than 2,000g of low birth weight infants who were admitted to NICU and GCU.
Key exclusion criteria
1) Neonate whose birth weight 2000g or more.
2) Infants with surgical diseases (esophageal atresia, diaphragmatic hernia, etc.), with low possibility of long-term enteral nutrition
3) Neonates judged to be ineligible by research facility director or research doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Chiba University School of Medicine
Division name
Department of Pediatrics
Zip code
260-8670
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL
043-222-7171
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Tanaka |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
260-8670
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL
043-222-7171
Homepage URL
happy_clover0708sao@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Bunsan Food Science
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
graduate school of medicine chiba university
Address
1-8-1 Inohana Chuo-ku Chiba
Tel
043-222-7171
shimojo@faculty.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038788
| 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 |
