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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010089
Receipt No. R000011814
Scientific Title Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-
Date of disclosure of the study information 2013/02/21
Last modified on 2016/11/13

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Basic information
Public title Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-
Acronym Effect of bifidobacterium enema in very low birth weight infants
Scientific Title Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-
Scientific Title:Acronym Effect of bifidobacterium enema in very low birth weight infants
Region
Japan

Condition
Condition Very low birth weight infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Low birth weight infants have immature digestive function. We have hypothesized that many live bacteria are died when enteral probiotics administration supplied to reach anus. Probiotics enema in very low birth weight infants may have better than a conventional enteral administration. In order to clarify these, we planned this study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Bacterial flora in the stool (1W-4W after bifidobacterium administration)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Gastric (placebo*)
Enema (bifidobacterium**)
*Placebo(bifidobactirum free, 3 times/day)
**Bifidobacterium(bifidobacterium. breve 1.5*10*9 cfu/dose, 3 times/day)
Interventions/Control_2 Gastric (bifidobacterium**)
Eenema (placebo*)
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 Very low birth weignt infants
Key exclusion criteria Congenital anomaly, immunodeficiency
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiko Motojima, Shoichi Ezaki, Yosuke Sudo
Organization Saitama Medical Center, Saitama Medical University
Division name Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 049-228-3890
Email s_ezaki@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Motojima
Organization Saitama Medical Center, Saitama Medical University
Division name Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 042-228-3727
Homepage URL
Email y_mtjm@saitama-med.ac.jp

Sponsor
Institute Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Research and information Center of Morinaga Milk

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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 21 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
2013 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2013 Year 02 Month 21 Day
Last modified on
2016 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011814

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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