UMIN-CTR Clinical Trial

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

Depression

Classification by specialty

Gastroenterology

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Showa University School of Medicine
Department of Psychiatry

Institute

Department

Personal name

Organization

Japan Dairy Association J-milk

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Keio University School of Medicine
Institute for Advanced Biosciences, Keio University

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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

2020

Year

12

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

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.

Registered date

2018

Year

09

Month

12

Day

Last modified on

2023

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038844