UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005175 |
|---|---|
| Receipt number | R000006143 |
| Scientific Title | Efficacy of BBG-01 (Bifidobacterium breve) on pre and postoperative infectious complications of infants in Juntendo University Hospital |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2024/03/11 13:35:16 |
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Basic information
Public title
Efficacy of BBG-01 (Bifidobacterium breve) on pre and postoperative infectious complications of infants in Juntendo University Hospital
Acronym
Efficacy of BBG-01 administration for infants
Scientific Title
Efficacy of BBG-01 (Bifidobacterium breve) on pre and postoperative infectious complications of infants in Juntendo University Hospital
Scientific Title:Acronym
Efficacy of BBG-01 administration for infants
Region
| Japan |
Condition
Condition
Pediatric inpatients scheduled for gastrointestinal and urogenital surgery
Classification by specialty
| Surgery in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of postoperative infectious complications
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
- Postoperative infectious complications
- Sepsis
- Intestinal microbiota
- Gastrointestinal function
Key secondary outcomes
- Length of hospital stay
- Blood biochemical indicators
- Intestinal environment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium breve
Interventions/Control_2
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children less than 15 years old who will undergo operations at the Department of Pediatric General and Urogenital Surgery of Juntendo University Hospital
Key exclusion criteria
- A subject who cannot ingest the test diet due to intestinal dysfunction.
- A subject whose operation is cancelled.
- A subject who is not suitable for the trial defined by the attending researcher.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsuyuki |
| Middle name | |
| Last name | Yamataka |
Organization
Juntendo University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-3813-3111
yama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tadaharu |
| Middle name | |
| Last name | Okazaki |
Organization
Juntendo University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-3813-3111
Homepage URL
okazakit@juntendo.ac.jp
Sponsor or person
Institute
Division of Laboratory for Probiotic Research, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Division of Laboratory for Probiotic Research, Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pediatric Surgery, Juntendo University School of Medicine
Name of secondary funder(s)
Yakult Honsha Co. Ltd.
IRB Contact (For public release)
Organization
Juntendo University Ethics Committee
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3813-3111
gakujutu@juntendo.ac.j
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
gakujutu@juntendo.ac.jp
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.juntendo.ac.jp/hospital/clinic/shonigeka/
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.lww.com/jpgn/Fulltext/2016/07000/Intestinal_Microbiota_in_Pediatric_Surgical_Cases.
Number of participants that the trial has enrolled
30
Results
BBG-01 was well tolerated without adverse effects, and postoperative infectious complications were significantly decreased. Fecal analysis showed increased Bifidobacterium and decreased Enterobacteriaceae, Clostridium difficile, and Pseudomonas. Concentrations of fecal acetic acid were significantly increased, maintaining fecal pH at <7.0. The incidence of detecting bacteria in blood was significantly reduced.
Results date posted
| 2023 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Because of my lack of awareness of reporting obligation.
Date of the first journal publication of results
| 2016 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Children who undergo surgery
Participant flow
Patients who underwent surgery at Juntendo University Hospital were included in this study.
Adverse events
None
Outcome measures
Post-operative course and complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006143
