UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041446 |
|---|---|
| Receipt number | R000047292 |
| Scientific Title | The effect of oral probiotics intake after birth on the intestinal microbiota of neonates: a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/08/17 18:15:19 |
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Basic information
Public title
The effect of oral probiotics intake after birth on the intestinal microbiota of neonates: a randomized control trial.
Acronym
The effect of oral probiotics intake after birth on the intestinal microbiota of neonates.
Scientific Title
The effect of oral probiotics intake after birth on the intestinal microbiota of neonates: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
The effect of oral probiotics intake after birth on the intestinal microbiota of neonates.
Region
| Japan |
Condition
Condition
Healthy neonates
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of oral probiotics after birth on gut flora in neonates born by a caesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut flora of newborns at 1 and 3 months of age
Key secondary outcomes
Biochemical analysis of stools
Urinary metabolite
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Probiotics is administered orally to newborns born by a cesarean section at birth, 1 day and 2 day after birth.
Interventions/Control_2
Placebo is administered orally to newborns born by a cesarean section at birth, 1 day and 2 day after birth.
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
Birth weight of 2000g or more
Key exclusion criteria
Twins
Pregnant women or newborns transferred to other hospital
Newborns with chromosomal anomaly and multiple malformation
Newborns whom a manager for this study judged to be inadequate as subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Hisata |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ken-hisa@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Hisata |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ken-hisa@umin.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Medicine Research Ethics Committee Secretariat
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
Tel
03-3813-3111
rinri@juntendo.ac.jp
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
浜田病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047292
