UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033758
Receipt number R000038367
Scientific Title A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.
Date of disclosure of the study information 2018/09/01
Last modified on 2022/12/25 22:21:21

* 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 double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.

Acronym

The heat-inactivated Pediococcus acidilactici K15 in preterm infant trial

Scientific Title

A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.

Scientific Title:Acronym

The heat-inactivated Pediococcus acidilactici K15 in preterm infant trial

Region

Japan


Condition

Condition

Prevention of viral respiratory tract infection

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this research is to evaluate the effect of inactivated Pediococcus K15 in prevention of viral respiratory tract infections for preterm infants after NICU discharge.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The number of febrile days during the exam period

Key secondary outcomes

The incidence of respiratory infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during respiratory infection. The incidence of respiratory syncytial virus (RSV) infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during RSV infection. Serum IgG,IgA and IgM levels before and after intervention. The adverse events associated with K15.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Pediococcus acidilactici K15 4.5mg(100mg included Dextrin),once a day, 12months

Interventions/Control_2

Dextrin,100mg, once a day, 12months

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

The preterm infants born at less than 35 weeks and graduated in NICU or GCU in our hospital

Key exclusion criteria

1)Patients with a precious allergy to Lactic acid bacteria or soy beans.
2)Patients with congenital heart disease, severe respiratory disease, chromosomal abnormality, and primary immunodeficiency disease.
3)Patients who were determined as unsuitable subjects by investigators.

Target sample size

70


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 Haruka
Middle name
Last name Hishiki

Organization

Chiba University Hospital

Division name

Department of Pediatrics

Zip code

2608670

Address

1-8-1 Inohana Chiba, Chuo-ku, Japan

TEL

043-222-7171

Homepage URL


Email

hishikih@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Kikkoman Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kikkoman Corporation
Osaka Ohtani University
Osaka university

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba university School of Medicine IRB

Address

1-8-1 Inohana Chiba, Chuo-ku, Japan

Tel

043-226-2841

Email

igaku-rinri@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

千葉大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 09 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

41

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

Completed

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB

2019 Year 01 Month 09 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 12 Month 01 Day

Date trial data considered complete

2022 Year 12 Month 07 Day

Date analysis concluded

2023 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 15 Day

Last modified on

2022 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name