UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028941 |
|---|---|
| Receipt number | R000033039 |
| Scientific Title | A study to investigate the effects of Bifidobacteria on stress relief: a randomized, double-blind, placebo-controlled, parallel-group comparative study. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/06/18 14:44:56 |
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Basic information
Public title
A study to investigate the effects of Bifidobacteria on stress relief: a randomized, double-blind, placebo-controlled, parallel-group comparative study.
Acronym
Effects of Bifidobacteria on stress relief.
Scientific Title
A study to investigate the effects of Bifidobacteria on stress relief: a randomized, double-blind, placebo-controlled, parallel-group comparative study.
Scientific Title:Acronym
Effects of Bifidobacteria on stress relief.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of Bifidobacteria on stress relief.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale questionnaire
Key secondary outcomes
Saliva stress marker, POMS, Autonomic nervous activity.
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of supplement containing Bifidobacteria for 8 weeks.
Interventions/Control_2
Ingestion of placebo for 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged more than 18 years, less than 65 years.
Key exclusion criteria
1)Subject who is under medication for chronic disease.
2)Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and these severe medical history.
3)Subject with serious allergy to specific medicine or food.
4)Subject who is pregnant or under lactation, or who is expected to be pregnant during the study.
5)Subject who constantly take medicines and/or supplements affecting gut microbiota.
6)Heavy drinker.
7)Subject who is ineligible due to physician's judgment.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Sugiura |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
mjc-k.sugiura@matsutan.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumi Yamashita |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
Homepage URL
mjc-t.yamasita@matsutan.ac.jp
Sponsor or person
Institute
Matsumoto Junior College
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Matsumoto Health Lab
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 01 | 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
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 31 | 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
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033039
