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 UMIN000041763
Receipt No. 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

* 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 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
Institute Osaka University
Institute
Department

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
URL(English) https://upload.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


Contact us.