UMIN-CTR Clinical Trial

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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