UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042315 |
|---|---|
| Receipt number | R000048305 |
| Scientific Title | A prospective observational study of gut microbiome in healthy controls in order to compare the data of gut microbiome in patients with depression |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/05/05 09:34:33 |
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Basic information
Public title
A prospective observational study of gut microbiome in healthy controls
Acronym
A prospective observational study of gut microbiome in healthy controls
Scientific Title
A prospective observational study of gut microbiome in healthy controls in order to compare the data of gut microbiome in patients with depression
Scientific Title:Acronym
A prospective observational study of gut microbiome in healthy controls
Region
| Japan |
Condition
Condition
Healthy controls
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the prospective observational study named "Gut microbiota of patients with depression and anxiety disorders"(UMIN000021833), we compare the data of gut microbiota and gut microbiota-derived metabolites between patients with depression and healthy controls. Thus, we will recruit participants with healthy controls.
Basic objectives2
Others
Basic objectives -Others
Potential correlations between mood or gastrointestinal symptoms and gut microbiota
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota profiles and its metabolites
Key secondary outcomes
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
Participants who are willing to participate in this study without a history of psychiatric disorders.
Key exclusion criteria
Participants with dementia.
Participants with gastrointestinal disorders.
Participants who are receiving antibiotic treatment.
Participants who can not agree with collecting faces samples.
Target sample size
40
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
03-3300-5232
ksanappu@gmail.com
Public contact
Name of contact person
| 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
03-3300-5232
Homepage URL
ksanappu@gmail.com
Sponsor or person
Institute
Showa University School of Medicine
Department of Psychiatry
Institute
Department
Personal name
Kenji Sanada
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
lnstitutional Review Board of Showa University Karasuyama Hospital
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo, Japan
Tel
0333005231
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048305
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048305
Number of participants that the trial has enrolled
10
Results
The target number of cases was reached, including the healthy subjects in the study titled "Prospective study of fecal microbiome
of elders with depression and healthy
controls (UMIN000034102)."
The composition of the gut microbiota and their metabolites will be published in a future paper.
Results date posted
| 2022 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were a total of 10 participants, 3 males and 7 females, with an average age of 63.4 years.
Participant flow
All assessments were completely performed with no dropouts in 10 participants.
Adverse events
Nothing particular
Outcome measures
Gut microbiota profiles and their metabolites
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect feces samples three times from healthy controls. Clinical information will also be collected with lifestyle habits and gastrointestinal symptoms.
Management information
Registered date
| 2020 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048305
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
