UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Title of the study (Brief title)	An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate efficacy of food containing lactic acid bacterium for anxiety symptoms of adults with anxiety feeling in daily lives
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	-Depression Index -Anxiety Index
Key secondary outcomes	-Anxiety Index -Mood Index -Intestinal Environment (Stool Frequency)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test food (8 weeks)
Interventions/Control_2	Intake of control food (8 weeks)
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Adult aged from 20 to 60 years old at time of informed consent was provided
Key exclusion criteria	1) Individuals with depression or who have diagnosed as a depression before 2) Individuals undergoing treatment for chronic disease 3) Individuals who have suicidal thoughts 4) Individuals who have allergy or who have history of sensitivity to the ingredients of test food 5) Individuals who are pregnant or nursing mother or individuals who are willing to become pregnant during this study 6) Individuals who participated in other clinical trials within 1 month 7) Individuals who intake medical chemicals or supplements that potentially influence the intestinal flora 8) Individuals who excessively take alcohol 9) Any Individuals considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	80

Research contact person
Name of lead principal investigator	Mamoru Hanyuuda
Organization	Breast Health Clinic
Division name	Breast Health Clinic
Address	3-8-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan
TEL	03-6667-0345
Email	imai@kt-medical.co.jp

Public contact
Name of contact person	Shigeru Imai
Organization	KT Medical Corporation
Division name	Food clinical trial Division
Address	6F 2-2-3 Marunouchi,Chiyoda-ku, Tokyo, Japan
TEL	03-6667-0345
Homepage URL
Email	imai@kt-medical.co.jp

Sponsor
Institute	KT Medical Corporation
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	KAYABA-CHO MENTAL HEALTH CARE CLINIC
Name of secondary funｄer(s)

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	ブレストヘルスクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 01 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040716