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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034102
Receipt No. R000038844
Scientific Title Prospective study of fecal microbiome of elders with depression and healthy controls.
Date of disclosure of the study information 2018/09/12
Last modified on 2020/03/14

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Basic information
Public title Prospective study of fecal microbiome of elders with depression and healthy controls.
Acronym Gut microbiome of elders with depression
Scientific Title Prospective study of fecal microbiome of elders with depression and healthy controls.
Scientific Title:Acronym Gut microbiome of elders with depression
Region
Japan

Condition
Condition Depression
Classification by specialty
Gastroenterology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We collect feces samples from elders with depression and healthy controls. Clinical information will also be collected with severity of each disease lifestyle habits and functional changes by using fMRI .
The purpose of this study is to investigate the difference between intestinal bacterial flora and its metabolites in each group and to examine the interaction between intestinal bacterial flora and neuropsychiatric function.
Basic objectives2 Others
Basic objectives -Others Potential correlation between mood or gastrointestinal symptom and microbiota
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feces samples will be collected at least three times during a month period.
Bacterial metagenome and metabolomics will be assessed with 16SrRNA methodology and Mass spectrometry.
Key secondary outcomes Original questionnaire of lifestyles
Brief-type self-administered Diet
History Questionnaire
Hamilton Depression Rating Scale
Hamilton Anxiety Scale
Montgomery-Asberg Depression Rating Scale
Pittsburgh Sleep Quality Index
Gastrointestinal Symptom Rating Scale
Original questionnaire of Gastro-
intestinal Symptom
fMRI

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
60 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with depression
Age above 60 years old at the time of agreement.
Patients with depression admitted to the Showa University Karasuyama Hospital or the Keio University Hospital.

Healthy participants
Elders who are willing to participate in this study without the history of psychiatric disorders.
Age above 60 years old at the time of agreement.
Key exclusion criteria Participants with dementia.
Participants with gastrointestinal
disorder.
Participants who are receiving the
antibiotic treatment.
Participants who can not agree
with collecting faces samples or
with taking the brain MRI.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Sanada
Organization Showa University School of Medicine
Division name Department of Psychiatry
Zip code 1578577
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo, Japan
TEL 03-3300-5232
Email ksanappu@gmail.com

Public contact
Name of contact person
1st name Katsuma
Middle name
Last name Miyaho
Organization Showa University School of Medicine
Division name Department of Psychiatry
Zip code 1578577
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo, Japan
TEL 03-3300-5232
Homepage URL
Email kylekorver0317@gmail.com

Sponsor
Institute Showa University School of Medicine
Department of Psychiatry
Institute
Department

Funding Source
Organization Japan Dairy Association J-milk
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Keio University School of Medicine
Institute for Advanced Biosciences, Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Karasuyama Hospital Department of IRB
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo, Japan
Tel 03-3300-5231
Email showa-crc@ofc.showa-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 昭和大学附属烏山病院(東京都)
慶應義塾大学病院(東京都)
慶應義塾大学先端生命科学研究所(山形県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 12 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
2018 Year 07 Month 13 Day
Date of IRB
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 5mm sized feces will be collected within 1 week after admission, 2 weeks, and 4 weeks. Patients' mood, state of feces and abdominal symptoms by using rating scales and functional changes by using fMRI will be evaluated .
Gut microbiota will be evaluated using restriction enzyme fragmentation approach.

Management information
Registered date
2018 Year 09 Month 12 Day
Last modified on
2020 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038844

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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