UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of probiotics on intestinal flora for surgical baby
Title of the study (Brief title)	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	MANABU OKAWADA
Organization	Juntendo University School of Medicine
Division name	Pediatric General & Urogenital Surgery
Address	Hongo 2-1-1, Bunkyo-ku tokyo
TEL	03-3813-3111
Email	manabu-o@juntendo.ac.jp

Public contact
Name of contact person	MANABU OKAWADA
Organization	Juntendo University School of Medicine
Division name	Pediatric General & Urogenital Surgery
Address	Hongo 2-1-1, Bunkyo-ku tokyo
TEL	03-3813-3111
Homepage URL
Email	manabu-o@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038540