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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004372
Receipt No. R000005221
Scientific Title Study of the preventive effect of probiotics on postoperative infection after colorectal surgery
Date of disclosure of the study information 2010/11/01
Last modified on 2020/09/01

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Basic information
Public title Study of the preventive effect of probiotics on postoperative infection after colorectal surgery
Acronym Kyorin Probiotics Study
Scientific Title Study of the preventive effect of probiotics on postoperative infection after colorectal surgery
Scientific Title:Acronym Kyorin Probiotics Study
Region
Japan

Condition
Condition Patients scheduled for rectal surgery and stoma closure
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 After colorectal surgery, SSI (surgical site infection) occurs at higher frequency than other gastroenterological surgery, and degrades patients QOL. It has been reported that probiotics has beneficial effect on immunity and bacteriostasis to H. Pylori, E. Coli and P. aeruginosa. There are some reports showing probiotics reduced the infection rate after cholangiocarcinoma surgery. However, there has been no report about colorectal cancer. This strategy is cheap and easy to perform. The number of colorectal surgery will increase in the future, therefore, we believe that this study will greatly contribute to surgical practice.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of SSI
Key secondary outcomes Changes of stool (bacteria, pH, organic acid) at pre-medication, pre-operation, and 5POD
Blood test (WBC, CRP, IL-6, NK activity) at pre-medication, pre-operation, 2POD, and 7POD

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 the grop takes lactic acid bacteria beverage for pre-operative 7 days and post-operative 7 days
Interventions/Control_2 control
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 1) Patients of 20-80 years old, scheduled for rectal surgery and stoma closure.
2) Patients who agree this clinical trial by themselves.
Key exclusion criteria Patients who had past history of colitis (ulcerative colitis: UC, Crohn's disease,MRSA colitis, pathogenic E. Coli colitis, pseudomembranous enterocolitis)
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Takaaki
Middle name
Last name Kobayashi
Organization Kyourin university hospital
Division name Department of surgery
Zip code 181-8611
Address 6-20-2 Shinkawa Mitka Tokyo
TEL 0422-47-5511
Email ck9t-kbys@asahi-net.or.jp

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name Kobayashi
Organization Kyourin university hospital
Division name Department of surgery
Zip code 181-8611
Address 6-20-2 Shinkawa Mitka Tokyo
TEL 0422-47-5511
Homepage URL
Email ck9t-kbys@asahi-net.or.jp

Sponsor
Institute Kyourin university hospital
Institute
Department

Funding Source
Organization Yakult Honsha Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyourin university hospital
Address 6-20-2 Shinkawa Mitka Tokyo
Tel 0422475511
Email ck9t-kbys@asahi-net.or.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 杏林大学病院（東京都）

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
Publication of results Unpublished

Result
URL related to results and publications https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
Number of participants that the trial has enrolled 16
Results 
1. intestinal flora
No significant change was observed for each bacterium.
2. stool organic acids
Total organic acid Preoperative: p=0.004 Postoperative: p=0.874
In the Yakult administration group, preoperative stool organic acids were significantly higher.
3. blood tests
No significant changes were observed in leukocyte/albumin/CRP/IL-6/NK activity.
4. SSI
Two cases occurred in the Yakult group.
No difference in SSI incidence was observed between the Yakult-treated group and the control group (p=0.169)
Results date posted
2020 Year 09 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Lower gastrointestinal surgery has a higher rate of SSI (surgical site infection), including wound infection, after surgery than other gastrointestinal surgery, and significantly reduces the postoperative QOL of patients.
Participant flow 
The target cases are divided into two groups, a Yakult-administered group and a non-administered group (control group), and the patients in the administration group receive a lactic acid bacterium beverage (Yakult 65) once a day for 7 days before surgery and for 7 days from the day after surgery. ..
Before administration, the day before surgery, and 5 days after surgery, stools will be collected to examine the incidence of SSI.
Adverse events 
Not specifically admitted
Outcome measures 
SSI incidence
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 10 Month 30 Day
Date of IRB
2017 Year 03 Month 31 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 12 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005221

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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