UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004704
Receipt No. R000005597
Scientific Title The effect of perioperative use of synbiotics in reducing infectious complications after surgery for esophageal cancer
Date of disclosure of the study information 2010/12/13
Last modified on 2010/12/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of perioperative use of synbiotics in reducing infectious complications after surgery for esophageal cancer
Acronym The effect of perioperative use of synbiotics in reducing infectious complications after surgery for esophageal cancer
Scientific Title The effect of perioperative use of synbiotics in reducing infectious complications after surgery for esophageal cancer
Scientific Title:Acronym The effect of perioperative use of synbiotics in reducing infectious complications after surgery for esophageal cancer
Region
Japan

Condition
Condition Surgical cases of esophageal cancer that receive esophagectomy
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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of postoperative infectious complications
Key secondary outcomes Inflammatory response (WBC, CRP, duration of SIRS), Abdominal symptoms(diarrhea, abdominal pain, interruption of enteral nutrition),fecal microflora, fecal organic acid, Bacterial translocation(endotoxin and bacteria in portal vein)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Yakult BL Seichoyaku (Yakult Honsha, Tokyo, Japan)
galactooligosaccharides (Oligomate S-HP, Yakult Honsha)
Interventions/Control_2 BIOFERMlN-R POWDER
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
80 years-old >=
Gender Male and Female
Key inclusion criteria patients with esophageal 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 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Yano
Organization Osaka Medical Center for Cancer and Cardiovascular Disease
Division name Department of surgery
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Tanaka
Organization Osaka Medical Center for Cancer and Cardiovascular Disease
Division name Department of surgery
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Disease
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Disease
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 13 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
2006 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 11 Day
Last modified on
2010 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.