Unique ID issued by UMIN | UMIN000033114 |
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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 | 2024/03/11 14:00:45 |
A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
Japan |
Prevention of colonization of S. aureus
Pediatrics |
Others
NO
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.
Safety,Efficacy
Colonization rate of S. aureus in specimens collected in feces, pharynx (nasal culture) up to 4 weeks after birth in each group.
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
2
Prevention
Food |
Administration of three bacterial species of Bifidobacterium
Administration of one bacterial spece of Bifidobacterium.
Not applicable |
Not applicable |
Male and Female
Less than 2,000g of low birth weight infants who were admitted to NICU and GCU.
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.
60
1st name | Naoki |
Middle name | |
Last name | Shimojo |
Chiba University School of Medicine
Department of Pediatrics
2608670
1-8-1 Inohana Chiba, Chuo-ku, Japan
043-222-7171
shimojo@faculty.chiba-u.jp
1st name | Kenichi |
Middle name | |
Last name | Takeshita |
Teikyo University Chiba medical center
Department of Pediatrics
2990111
3426-3 Anesaki Ichihara, Chiba, Japan
0436-62-1211
take1nek@yahoo.co.jp
Chiba University
Chiba University
Other
Chiba University Hospital
1-8-1 Inohana Chiba, Chuo-ku, Japan
043-222-7171
shiken@office.chiba-u.jp
NO
2018 | Year | 06 | Month | 22 | Day |
Unpublished
No longer recruiting
2018 | Year | 06 | Month | 20 | Day |
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 12 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2018 | Year | 06 | Month | 22 | Day |
2024 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037763
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