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 2024/03/11 14:00:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


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

No longer recruiting

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 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037763


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name