UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033114 |
|---|---|
| Receipt number | R000037763 |
| Scientific Title | A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria |
| Date of disclosure of the study information | 2018/06/22 |
| Last modified on | 2024/12/31 21:12:49 |
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Basic information
Public title
A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Acronym
Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
Scientific Title
A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Scientific Title:Acronym
Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
Region
| Japan |
Condition
Condition
Prevention of colonization of S. aureus
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare effect of one strain of Bifidobacterium vs 3 strains of Bifidobacterium on S. aureus colonization in low birth weight infants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Colonization rate of S. aureus in specimens collected in feces, pharynx (nasal culture) up to 4 weeks after birth in each group.
Key secondary outcomes
Measurement of the numbers of three strains Bifidobacterium and Staphylococcus aureus in each group in feces collected at 1 week, 2 weeks and 4 weeks after birth.
Difference between the age of each group and birth weight reversion
Correlation between weight gain rate and each group at week 40 weeks in preterm infants
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of three bacterial species of Bifidobacterium
Interventions/Control_2
Administration of one bacterial spece of Bifidobacterium.
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 is 2000g or more.
2) Infants with a surgical disease (esophageal atresia, diaphragmatic hernia, etc.), long-term enteral nutrition / oral medication administration can not be expected.
3) Neonate who 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
2608670
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 | Kenichi |
| Middle name | |
| Last name | Takeshita |
Organization
Teikyo University Chiba medical center
Division name
Department of Pediatrics
Zip code
2990111
Address
3426-3 Anesaki Ichihara, Chiba, Japan
TEL
0436-62-1211
Homepage URL
take1nek@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Hospital
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
Tel
043-222-7171
shiken@office.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 | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/bmfh/43/4/43_2023-093/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/bmfh/43/4/43_2023-093/_article/-char/en
Number of participants that the trial has enrolled
39
Results
No severe adverse events occurred in either group during the study period. Although no significant difference was detected between single- and multi-strain bifidobacteria supplementation in the colonization of Staphylococcus in the fecal microbiota of the neonates, multi-strain bifidobacteria supplementation contributed toward early enrichment of the microbiota with bifidobacteria and suppression of other pathogenic bacteria, such as Clostridium spp.
Results date posted
| 2024 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 39 neonates weighing less than 2,000 g at birth and admitted to the neonatal intensive care unit at Chiba University Hospital between January 2019 and September 2020 were enrolled.
The median gestational ages of the single- and triple-strain groups were both 32 weeks. The median birth weights of the two groups were 1,377 g (558-1,943 g) and 1,465 g (717-1,907 g), and the proportions of extreme and very LBWNs in each group were 66.7% and 55.6%, respectively. There was no significant difference in the baseline characteristics of the two groups.
Participant flow
A total of 39 neonates were enrolled in this study; 19 were randomly assigned to the single-strain group, and 20 were randomly assigned to the triple-strain group. Three neonates did not attend follow-up visits, and the data of the remaining 36 neonates (18 neonates in each group) were analyzed.
Adverse events
No adverse events (poor weight gain, severe abdominal symptoms, or death) occurred following probiotic supplementation in either group during the study period.
Outcome measures
The relative abundances of Staphylococcus and Bifidobacterium in the fecal microbiota at weeks 1, 2, and 4 were investigated. Based on the study results, no significant difference was detected between the two groups in the abundance of Staphylococcus; however, the triple-strain group had significantly high abundances of Bifidobacterium at weeks 2 and 4. The fecal microbiota in the triple-strain group had significantly lower alpha diversity (Bifidobacterium-enriching) after week 4 and was different from that in the single-strain group, which showed a higher abundance of Clostridium. No severe adverse events occurred in either group during the study period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037763
