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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034023
Receipt No. 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 2018/10/29

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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
Middle name
Last name Naoki Shimojo
Organization Chiba University School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL 043-222-7171
Email shimojo@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruka Takei
Organization Chiba University Hospital
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL 043-222-7171
Homepage URL
Email kagawaharukah@hotmail.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
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
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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