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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038095
Receipt No. 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 2019/09/25

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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
Email 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
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Unviersity
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 25 Day
Date of IRB
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
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043423

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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