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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Patients scheduled for rectal surgery and stoma closure | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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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 |
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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 | |
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 |
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 |
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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) |
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Results date posted |
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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. |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |