UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050952 |
|---|---|
| Receipt number | R000058075 |
| Scientific Title | Effects of Probiotic intake on the autonomic nervous system: Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/04/25 12:25:55 |
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Basic information
Public title
Investigation of effects of Probiotic on the autonomic nervous system
Acronym
Impacts of Probiotic on the autonomic nervous system
Scientific Title
Effects of Probiotic intake on the autonomic nervous system: Randomized Controlled Trial
Scientific Title:Acronym
RCT of Probiotic intake
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify how Probiotic intake has effects on the autonomic nervous system and leads to a sustained good mood or sleep quality or to a better state.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indices of the autonomic nervous system function calculated from heart rate variability (RR interval, HF, LF/HF, CVRR, SDNN, RMSSD, NN50, pNN50)
Key secondary outcomes
Mean activity level, questionnaires (CES-D, STAI, PSQI), sleep EEG (sleep onset latency, percentage of non-REM sleep stage 3, mean sleep cycle, sleep efficiency, delta power value per minute of first sleep cycle), blood tests (inflammatory markers, cortisol), gut bacterial count (Bifidobacterium, Atopobium cluster, and lactobacilli)
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of beverages, which contains Probiotic, Lacticaseibacillus paracasei YIT 9029 (strain Shirota)
Interventions/Control_2
Intake of beverages not containing Probiotic (control)
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
Depression Self-Rating Scale (Center for Epidemiologic Studies-Depression Scale: CES-D) total score between 12 and 30 points
Key exclusion criteria
1) patients with cardiac, hepatic or renal impairments, hematologic or pulmonary diseases, or with a past history of these illnesses
2) patients who meet the diagnosis of major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition), or who are under treatment for psychiatric illnesses at medical institutions
3) patients with the history of substance-related and addictive disorders or feeding and eating disorders
4) people with a history of clinically serious allergies
5) people with suicidal ideas: a score of 2 or more on item 9 of the Beck Depression Inventory 2nd edition (BDI-II)
6) people with intestinal illnesses without organic causes or with a history of such diseases
7) people with dementia or intellectual disability
8) patients with diabetes mellitus or with a history of diabetes mellitus
9) pregnant or possibly pregnant women
10) people who have a history of serious head injuries or central nervous system diseases
11) people with a pacemaker
12) people who are allergic to milk or soy
13) people with lactose intolerance
14) people taking probiotics, drugs for intestinal condition and antibiotics regularly
15) people who the research director or researchers judge do not suit for the candidates for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kunugi |
Organization
Teikyo University, Faculty of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
173-8605
Address
Tokyo-to Itabashi-ku Kaga 2-1-11
TEL
03-3964-1211
hkunugi@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kunugi |
Organization
Teikyo University, Faculty of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
173-8605
Address
Tokyo-to Itabashi-ku Kaga 2-1-11
TEL
03-3964-1211
Homepage URL
hkunugi@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
Tokyo-to Itabashi-ku Kaga 2-1-11
Tel
03-3964-7256
turb-office@teikyo-u.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
| 2024 | Year | 03 | 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
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 04 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058075
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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