UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021833 |
|---|---|
| Receipt number | R000025172 |
| Scientific Title | Gut microbiota of patients with depression and anxiety disorders: A prospective observational study |
| Date of disclosure of the study information | 2016/04/07 |
| Last modified on | 2023/10/15 05:56:10 |
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Basic information
Public title
Gut microbiota of patients with depression and anxiety disorders: A prospective observational study
Acronym
Gut microbiota of patients with depression and anxiety disorders
Scientific Title
Gut microbiota of patients with depression and anxiety disorders: A prospective observational study
Scientific Title:Acronym
Gut microbiota of patients with depression and anxiety disorders
Region
| Japan |
Condition
Condition
Depressive disorders, anxiety disorders
Classification by specialty
| Gastroenterology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see if gut microbiota of depressive and anxiety disorders change along with psychiatric treatments
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
Gut microbiota(baseline, approx. 2 weeks, 4 weeks)
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
Inpatinets with depressive disorders and anxiety disorders
Key exclusion criteria
Patients who are receiving antibiotic treatment
Patients whose psychiatric condition can exacerbate due to feces collection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kishimoto |
| Middle name | |
| Last name | Taishiro |
Organization
Keio university school of medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Kurokawa |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5363-3492
Homepage URL
shunya5@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Komagino hospital
Showa University Karasuyama Hospital
Institute for Advanced Biosciences, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Review Subcommittee
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0353633611
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
駒木野病院（東京都）
昭和大学附属烏山病院（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
| 2016 | Year | 04 | Month | 07 | 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
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2020 | 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 will be evaluated using rating scales.
Gut microbiota will be evaluated using restriction enzyme fragmentation approach.
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025172
