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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003262
Receipt No. R000003829
Scientific Title The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Date of disclosure of the study information 2010/02/28
Last modified on 2019/03/06

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Basic information
Public title The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Acronym The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Scientific Title The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Scientific Title:Acronym The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Region
Japan

Condition
Condition surgical cases of esophageal cancer and gastric cancer that need open chest procedure
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of perioperative synbiotics treatment in preventing postoperative infectious complications in surgical cases of esophageal cancer and gastric cancer that need open chest procedure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative infectious complications/ Surgery-related mortality/ In hospital days
Key secondary outcomes Inflammatory response by blood test
Bacterial translocation during operation confirmed by the analysis of mesenteric lymph nodes.
Incidence of postoperative bacteremia.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Yakult 400 (Yakult Honsha, Tokyo, Japan)
Bifiene S (Yakult Honsha)
galactooligosaccharides (Oligomate S-HP, Yakult Honsha; 15 g/day)
Interventions/Control_2 Control: no treatment
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 esophageal and gastric cancer who fulfilled the criteria of this study and agreed with the enrollment in this study
Key exclusion criteria patients who reject to be enrolled in this study
patients who do not fulfill the criteria of this study
Target sample size 30

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 nagino@med.nagoya-u.ac.jp

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 nagino@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Unviersity Graduate School of Medicine
Institute
Department

Funding Source
Organization Yakult Central Institute for Microbiological Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 28 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
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 27 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003829

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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