UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004372 |
|---|---|
| Receipt number | 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 19:31:42 |
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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
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
ck9t-kbys@asahi-net.or.jp
Sponsor or person
Institute
Kyourin university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005221
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| Registered date | File name |
| Research case data | |
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