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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033805
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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