UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041763
Receipt number R000047664
Scientific Title A randomized clinical trial of symbiotic treatment before surgery for locally recurrent rectal cancer
Date of disclosure of the study information 2020/09/14
Last modified on 2020/09/11 16:51:33

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Basic information

Public title

A randomized clinical trial of symbiotic treatment before surgery for locally recurrent rectal cancer

Acronym

A randomized clinical trial of symbiotic treatment before surgery for locally recurrent rectal cancer

Scientific Title

A randomized clinical trial of symbiotic treatment before surgery for locally recurrent rectal cancer

Scientific Title:Acronym

A randomized clinical trial of symbiotic treatment before surgery for locally recurrent rectal cancer

Region

Japan


Condition

Condition

locally recurrent rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to investigate the efffect of synbiotics in surgery for locally recurrent rectal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of surgical site infection after surgery

Key secondary outcomes

The effect of preventing adverse event in pre-operative chemoradiation therapy.

The influences in immunological ability caused by pre-operative chemoradiation therapy.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

Biolactis powder containing living Lactobacillus casei strain Shirota, BBG01 containing living Bifidobacterium breve strain Yakult, and galactooligosaccharides were administered.
Dosage
Biolactic powder, 3g per day
BBG01, 3g per day
Galactooligosaccharides, Oligomate SHP, 15g per day

Interventions/Control_2

patients without synbiotisc

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with locally recurrent rectal cancer.
Patients who are going to receive pre-operative chemoradiation therapy and surgery.
Patients who agreed the participation of this study.

Key exclusion criteria

Not applicable

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Uemura

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2 E2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Email

uemura7777@hotmail.com


Public contact

Name of contact person

1st name Mamoru
Middle name
Last name Uemura

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2 E2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Homepage URL


Email

uemura7777@hotmail.com


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha, Tokyo, Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp


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

2020 Year 09 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

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

2007 Year 08 Month 06 Day

Date of IRB

2008 Year 05 Month 22 Day

Anticipated trial start date

2008 Year 06 Month 04 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 11 Day

Last modified on

2020 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name