UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010089 |
|---|---|
| Receipt number | 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 08:12:20 |
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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
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
y_mtjm@saitama-med.ac.jp
Sponsor or person
Institute
Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011814
