UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035746
Receipt No. R000040716
Scientific Title An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Date of disclosure of the study information 2019/06/30
Last modified on 2019/02/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Acronym An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Scientific Title An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Scientific Title:Acronym 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
1st name
Middle name
Last name Mamoru Hanyuuda
Organization Breast Health Clinic
Division name Breast Health Clinic
Zip code
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
1st name
Middle name
Last name Shigeru Imai
Organization KT Medical Corporation
Division name Food clinical trial Division
Zip code
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)

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 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

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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.