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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007651
Receipt No. 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 2012/04/16

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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
Email

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
Email mafukaya@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 23 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 03 Day
Last modified on
2012 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009023

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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