UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038095 |
|---|---|
| Receipt number | R000043423 |
| Scientific Title | The effects of synbiotics for improving the intestinal microenvironment. A randomized controlled study |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2022/09/27 10:43:50 |
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Basic information
Public title
The effects of synbiotics for improving the intestinal microenvironment. A randomized controlled study
Acronym
The effects of synbiotics for improving the intestinal microenvironment. A randomized controlled study
Scientific Title
The effects of synbiotics for improving the intestinal microenvironment. A randomized controlled study
Scientific Title:Acronym
The effects of synbiotics for improving the intestinal microenvironment. A randomized controlled study
Region
| Japan |
Condition
Condition
patients who are scheduled to undergo highly invasive abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the beneficial effect of synbiotics (a combination of probiotics and synbiotics) in improving intestinal microenvironment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the changes of intestinal microenvironment profile, fecal organic acid concentrations, and pH before and after an administration of probiotics, prebiotics, and synbiotics.
Key secondary outcomes
Compare the changes of blood tests before and after an administration of probiotics, prebiotics, and synbiotics.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of probiotics for 2 weeks.
Interventions/Control_2
Oral intake of prebiotics for 2 weeks.
Interventions/Control_3
Oral intake of synbiotics for 2 weeks.
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 who are scheduled to undergo highly invasive abdominal surgery; including major hepatectomy, hepatopancreatoduodenectomy, pancreatoduodenectomy, pancreatectomy with celiac axis resection, subtotal esophagectomy, and other equivalent highly invasive abdominal surgery.
Key exclusion criteria
Patients who refused to participate the study.
Patients with severe cognitive disorder.
Patients who are not eligible for this study according to the physician's decision.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University
Division name
Department of Surgery, Division of Perioperative Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | Yokoyama |
| Last name | Yokoyama |
Organization
Nagoya University
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
466-8550
Address
65
TEL
0527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Unviersity
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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, Nagoya, Aichi, Japana
Tel
0527442479
ethics@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043423
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
