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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name