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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021833
Receipt No. 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 2018/06/12

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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
Last name of lead principal investigator
1st name
Middle name
Last name Taishiro Kishimoto
Organization Keio university school of medicine
Division name Neuropsychiatric department
Zip code
Address 35 Shinanomachi Shinjuku Tokyo
TEL 0333531211
Email tkishimoto@keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Taishiro Kishimoto
Organization Keio University School of Medicine
Division name Neuropsychiatric department
Zip code
Address 35 Shinanomachi Shinjuku Tokyo
TEL 0333531211
Homepage URL
Email tkishimoto@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 07 Day
Last follow-up date
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
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025172

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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