UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003262 |
|---|---|
| Receipt number | R000003829 |
| Scientific Title | The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer. |
| Date of disclosure of the study information | 2010/02/28 |
| Last modified on | 2022/03/08 09:32:03 |
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Basic information
Public title
The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Acronym
The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Scientific Title
The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Scientific Title:Acronym
The effect of synbiotics in protecting infectious complications following surgeries for esophageal and gastric cancer.
Region
| Japan |
Condition
Condition
surgical cases of esophageal cancer and gastric cancer that need open chest procedure
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of perioperative synbiotics treatment in preventing postoperative infectious complications in surgical cases of esophageal cancer and gastric cancer that need open chest procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative infectious complications/ Surgery-related mortality/ In hospital days
Key secondary outcomes
Inflammatory response by blood test
Bacterial translocation during operation confirmed by the analysis of mesenteric lymph nodes.
Incidence of postoperative bacteremia.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Yakult 400 (Yakult Honsha, Tokyo, Japan)
Bifiene S (Yakult Honsha)
galactooligosaccharides (Oligomate S-HP, Yakult Honsha; 15 g/day)
Interventions/Control_2
Control: no treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with esophageal and gastric cancer who fulfilled the criteria of this study and agreed with the enrollment in this study
Key exclusion criteria
patients who reject to be enrolled in this study
patients who do not fulfill the criteria of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Fukaya |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
0527442218
Homepage URL
nagino@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Unviersity Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute for Microbiological Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku
Tel
0527442218
yyoko@med.nagoya-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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0261561421004738?via%3Dihub
Number of participants that the trial has enrolled
42
Results
The study recruited a total of 42 patients (22 in the control group, 20 in the synbiotics group). Bacteria were detected in 16 of 101 blood samples in the control group, whereas those were detected only 2 of 100 blood samples in the synbiotics group (p < 0.001) during neoadjuvant chemotherapy. Additionally, bacteria were detected in 12 of 34 MLN samples in the control group, whereas no bacteria were detected in 38 MLN samples in the synbiotics group (p < 0.001).
Results date posted
| 2022 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Methods: Patients requiring neoadjuvant chemotherapy for esophageal cancer were randomized to receive synbiotics (synbiotics group) or no synbiotics (control group) during chemotherapy. Blood and fecal samples were taken before and after every chemotherapy cycle, and 1 day before surgery. Mesenteric lymph nodes (MLNs) were harvested at laparotomy (MLN-1) and after resection of the tumor (MLN-2). Bacteria in each sample were detected. Fecal microbiota and organic acid concentrations were also determined.
Participant flow
Methods: Patients requiring neoadjuvant chemotherapy for esophageal cancer were randomized to receive synbiotics (synbiotics group) or no synbiotics (control group) during chemotherapy. Blood and fecal samples were taken before and after every chemotherapy cycle, and 1 day before surgery. Mesenteric lymph nodes (MLNs) were harvested at laparotomy (MLN-1) and after resection of the tumor (MLN-2). Bacteria in each sample were detected. Fecal microbiota and organic acid concentrations were also determined.
Adverse events
None
Outcome measures
The primary endpoint was the detection of bacteria in the blood samples, as well as the incidence of side effects during chemotherapy. The secondary endpoint was the detection rate of bacteria in the MLN samples collected during surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003829
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/03/08 | 3_研究計画書（介入研究）_計画書シンバイオティックス+期間更新 ｖ5+(1)0702.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
