UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043901 |
|---|---|
| Receipt number | R000050132 |
| Scientific Title | Intestinal-brain association of depression,Imaging metabolomics Research |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2023/12/15 11:59:21 |
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Basic information
Public title
Intestinal-brain association of depression,Imaging metabolomics Research
Acronym
Intestinal bacteria and brain function of depression
Scientific Title
Intestinal-brain association of depression,Imaging metabolomics Research
Scientific Title:Acronym
Intestinal bacteria and brain function of 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 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.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 Ratin
g Scale
Pittsburgh Sleep Quality Index
Gastrointestinal Symptom Rating Scale
Original questionnaire of Gastrointestinal 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with depression
Age above 20 years old at the time of agreement.Patients with depression attended or admitted to the Showa University Karasuyama Hospital.
Healthy participants
The Adult who are willing to participate in this study without the history of psychiatric disorders.
Age above 20 years old at the time of agreement.
Key exclusion criteria
Participants with dementia.
Participants with gastro intestinal 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
80
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
157-8577
Address
6-11-11 Kita karasuyama Setagaya-ku, Tokyo, Japan
TEL
0333005231
ksanappu@gmail.com
Public contact
Name of contact person
| 1st name | Shutaro |
| Middle name | |
| Last name | Sugita |
Organization
Showa University School of Medicine
Division name
Department of Psychiatry
Zip code
157-8577
Address
6-11-11 Kita karasuyama Setagaya-ku, Tokyo, Japan
TEL
0333005231
Homepage URL
shutaro.sugita.06@gmail.com
Sponsor or person
Institute
Showa University School of Medicine Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Other
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 School of Medicine Department of Psychiatry
Address
6-11-11 Kita karasuyama Setagaya-ku, Tokyo, Japan
Tel
0333005231
ksanappu@gmail.com
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
| 2021 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | 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. 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
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050132
