UMIN-CTR Clinical Trial

Basic information
Public title	The effect of a prebiotic lactosucrose on intestinal microbiota and eating habits in patients with depression
Acronym	The effect of lactosucrose on health condition in depressed patients
Scientific Title	The effect of a prebiotic lactosucrose on intestinal microbiota and eating habits in patients with depression
Scientific Title:Acronym	The effect of lactosucrose on health condition in depressed patients
Region	Japan

Condition
Condition	depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the effect of a prebiotic lactosucrose in depressed patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in following parameters six months after the start of lactosucrose. 1)Body data 2)Blood data 3)Mental symptoms 4)Self-efficacy 5)QOL 6)Content of fat and carbohydrate in feces 7)Frequency of stool and fecal characteristics 8)Dietary intake 9)Efforts to improve dietary habits 10)Medication situation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	Eating prebiotics(Lactosucrose)
Interventions/Control_2	Nutritional education once a month
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	Outpatients with depression treated at Osaka Institute of Psychiatry Shin-Abuyama Hospital
Key exclusion criteria	1) subjects who do not accept the informed consent 2) subjects who routinely take prebiotics or probiotics
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yumiko Middle name Last name Ido
Organization	BAIKA Women's University
Division name	Faculty of Food Culture, Department of Health and Nutrition
Zip code	567-8578
Address	2-19-5, Shukunosho, Ibaraki, Osaka, Japan
TEL	072-548-2519
Email	y-ido@baika.ac.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Omori
Organization	BAIKA Women's University
Division name	Faculty of Food Culture, Department of Health and Nutrition
Zip code	567-8578
Address	2-19-5, Shukunosho, Ibaraki, Osaka, Japan
TEL	072-548-2519
Homepage URL
Email	yori.0012@gmail.com

Sponsor
Institute	BAIKA Women's University
Institute
Department

Funding Source
Organization	Osaka Institute of Psychiatry Shin-Abuyama Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Doshisha women's College, Osaka Institute of Psychiatry Shin-Abuyama Hospital
Name of secondary funder(s)	Doshisha women's College

IRB Contact (For public release)
Organization	Doshisha women's College
Address	Kodo, Kyotanabe, Kyoto
Tel	0774-65-8679
Email	research@dwc.doshisha.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	2018 Year 01 Month 24 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	2018 Year 04 Month 01 Day
Date of IRB	2017 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035368