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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035635
Receipt No. R000040594
Scientific Title The impact of the gut microbiome in obesity
Date of disclosure of the study information 2019/04/01
Last modified on 2019/12/29

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Basic information
Public title The impact of the gut microbiome in obesity
Acronym The gut microbiome in obesity
Scientific Title The impact of the gut microbiome in obesity
Scientific Title:Acronym The gut microbiome in obesity
Region
Japan

Condition
Condition obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To investigate the relationship between obesity and the gut microbiome and its metabolites.
Basic objectives2 Others
Basic objectives -Others To identify probiotics which could inhibit obesity by altering the gut microbiome.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The gut microbial and metabolic alterations during weight-loss intervention by surgery in obesity patients.
Key secondary outcomes The alterations of the gut microbiome and its metabolites after culturing with probiotics in vitro.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. The obesity patients undergoing weight-loss surgery.
2. Patients who agreed to study participants
Key exclusion criteria 1. patients with antibiotic use within 1 month.
2. patients who take amino acids supplements.
3. patients with disorders of branched-chain amino acid metabolism
4. patients who participate other clinical intervention studies within 4 months.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tomoya
Middle name
Last name Yamashita
Organization Kobe university hospital
Division name Division of Cardiovascular Medicine
Zip code 658-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Email tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Tomoya
Middle name
Last name Yamashita
Organization Kobe university hospital
Division name Division of Cardiovascular Medicine
Zip code 658-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Homepage URL
Email tomoya@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Kobe university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chibune hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Address Kobe University Clinical Research Ethical Committee
Tel 078-382-6669
Email cerb@med.kobe-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
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 03 Month 18 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. The gut microbial and metabolic alterations during weight-loss intervention by surgery in obesity patients.
2. The alterations of the gut microbiome and its metabolites after culturing with probiotics in vitro.

Management information
Registered date
2019 Year 01 Month 23 Day
Last modified on
2019 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040594

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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