UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033805
Receipt number R000038540
Scientific Title The efficacy of probiotics on intestinal flora for surgical baby
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/19 23:22:08

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Basic information

Public title

The efficacy of probiotics on intestinal flora for surgical baby

Acronym

The efficacy of probiotics on intestinal flora for surgical baby

Scientific Title

The efficacy of probiotics on intestinal flora for surgical baby

Scientific Title:Acronym

The efficacy of probiotics on intestinal flora for surgical baby

Region

Japan


Condition

Condition

congenital anomaly

Classification by specialty

Surgery in general Pediatrics Operative medicine
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate how intestinal flora in neonatal surgery cases changes by probiotic treatment and new bacterial flora is established.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Cytokines in blood (IL6, IL10, IL12, IL18, IFNg), IgG, IgA, IgE are measured. DNA analysis of intestinal microflora in feces with next generation sequencer.
For each item, compare with neonatal surgery case / non-surgical case.
Blood and fecal samples should be taken at the following schedule.
(Surgery case: at birth, immediately before surgery, immediately after surgery, 1st day after surgery, 3rd day, 7th day
Non-surgical case: at birth, 1st day after birth, 3rd day, 7th day)
We will examine the correlation between postoperative clinical course and the above results.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

After starting feeding, 1 kg of LKM 512 bifidus per day and taking it until discharge date (14 - 28 days)

Interventions/Control_2

Of the newborn hospital admitted to our hospital (including cases transferred from other hospital births), it is divided into 2 groups of surgical cases, surgery not yet performed, and normal neonates

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

1 days-old <=

Age-upper limit

28 days-old >=

Gender

Male and Female

Key inclusion criteria

Of the newborn hospital admitted to our hospital (including cases transferred from other hospital births), surgical cases, non surgical cases, normal newborns are examined
1) From Committee Approval date to born on March 1, 2019
2) The presence or absence of serious complication malformation (chromosomal abnormality, complex heart disease) is not required
3) Whether actively treated, palliative or restrictive treatment was selected

Key exclusion criteria

1) The patient was considered prenatally diagnosed as requiring surgery but was aborted or in utero fetal death.
2) Patients who underwent surgery after 28 days of age

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name MANABU OKAWADA

Organization

Juntendo University School of Medicine

Division name

Pediatric General & Urogenital Surgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku tokyo

TEL

03-3813-3111

Email

manabu-o@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name MANABU OKAWADA

Organization

Juntendo University School of Medicine

Division name

Pediatric General & Urogenital Surgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku tokyo

TEL

03-3813-3111

Homepage URL


Email

manabu-o@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyodo Milk Industry Co. Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyodo Milk Industry Co. Ltd

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

順天堂大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 20 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

Enrolling by invitation

Date of protocol fixation

2017 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 19 Day

Last modified on

2018 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name