UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007651 |
|---|---|
| Receipt number | R000009023 |
| Scientific Title | The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications |
| Date of disclosure of the study information | 2012/04/03 |
| Last modified on | 2022/04/20 13:02:20 |
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Basic information
Public title
The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications
Acronym
The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications
Scientific Title
The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications
Scientific Title:Acronym
The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of synbiotics during neoadjuvant chemo(radio)therapy for esophageal cancer in preventing bacterial translocation and postoperative infectious complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Existance of bacterical translocation
Key secondary outcomes
Side effect of chemo(radio)therapy
Inflammatory marker during chemo(radio)therapy
Statement of nurtrition after chemo(radio)therapy
Permeability of intestinal mucosa
Grading of atrophy of intestinal mucosa
Postoperative complication
Inflammatory marker after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
Synbiotic treatment during chemo(radio)therapy; oral intake, Yakult 400 (Yakult Honsha, Tokyo, Japan) containing living Lacobacillus casei strain Shirota; BifieneS (Yakulut Honsha) containing living Bifisobacterium breve strain Yakult and galactooligosaccharides.
Postoperative symbiotic treatment, through the enteral feeding tube, Yakult BL Seichoyaku (Yakult Honsha) and galactoorigosaccharides (Oligomate S-HP)
Interventions/Control_2
Postoperative symbiotic treatment, through the enteral feeding tube, Yakult BL Seichoyaku (Yakult Honsha) and galactoorigosaccharides (Oligomate S-HP)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with resctable esophageal cancer requiring neoadjuvant chemo(radio)therapy
Key exclusion criteria
Patients with infectious disease before chemo(radio)therapy
Patients with previous chemo(radio)thrapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Fukaya |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
Homepage URL
mafukaya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yakult Central Institute for Microbiological Research
Name of secondary funder(s)
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
名古屋大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 03 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009023
