UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048189 |
|---|---|
| Receipt number | R000054890 |
| Scientific Title | Clinical study on changes in gut microbiota and the effect of bifidobacterium administration in postoperative patients with esophageal cancer |
| Date of disclosure of the study information | 2022/06/29 |
| Last modified on | 2023/06/30 10:32:43 |
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Basic information
Public title
Clinical study on changes in gut microbiota and the effect of bifidobacterium administration in postoperative patients with esophageal cancer
Acronym
Clinical study on bifidobacterium administration in esophageal cancer patients
Scientific Title
Clinical study on changes in gut microbiota and the effect of bifidobacterium administration in postoperative patients with esophageal cancer
Scientific Title:Acronym
Clinical study on bifidobacterium administration in esophageal cancer patients
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of bifidobacterium administration on changes in gut microbiota of postoperative esophageal cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
abundance of proteobacteria in feces
Key secondary outcomes
1) Species and diversity score of gut microbiota
2) Gastrointestinal symptoms after surgery
3) Frequency and severity of infectious complications
4) Frequency and severity of other postoperative complications
5) Length of hospital stay after surgery
6) Nutritional intake
7) Blood test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One sachet of bifidobacterium powder is administered in the evening of the first postoperative day. From the second to the seventh postoperative day, One sachet of bifidobacterium powder is administered three times a day.
Interventions/Control_2
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
1) Patients with stage 2 and 3 esophageal cancer who are scheduled to undergo esophagectomy.
2) Patients who are scheduled to start enteral nutrition according to the clinical pathway of this hospital after surgery.
3) Patients with or without preoperative chemotherapy
4) Patients with or without multiple cancers
5) Patients 20 years of age or older
6) Patients who can obtain informed consent from the patient
Key exclusion criteria
1) Patients with Performance Status of 3 or higher
2) Patients with serious complications such as poorly controlled diabetes mellitus or hypertension
3) Patients with muscle diseases including active myopathy or muscular dystrophy
4) Patients who are pregnant or lactating
5) Patients who participated in clinical trial or clinical research involving the use of an unapproved drug and received an investigational drug or unapproved drug at least 16 weeks prior to the informed consent
6) Patients who are determined to be ineligible for this study by the principal investigator or subinvestigator
7) Patients who are allergic to the study food
8) Patients who failed to obtain informed consent or withdrew informed consent
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Ogawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterological Surgery
Zip code
467-0001
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8226
r-ogawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ogawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterological Surgery
Zip code
467-0001
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8226
Homepage URL
r-ogawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Clinico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Institutional Review Board
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2022 | Year | 06 | Month | 29 | 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
15
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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | 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
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054890
