UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050539 |
|---|---|
| Receipt number | R000057556 |
| Scientific Title | The effect of probiotics, paraprobiotics, and synbiotics on sleep metrics: systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2023/09/06 14:52:37 |
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Basic information
Public title
The effect of probiotics, paraprobiotics, and synbiotics on sleep metrics: systematic review and meta-analysis
Acronym
The effect of probiotics, paraprobiotics, and synbiotics on sleep metrics: systematic review and meta-analysis
Scientific Title
The effect of probiotics, paraprobiotics, and synbiotics on sleep metrics: systematic review and meta-analysis
Scientific Title:Acronym
The effect of probiotics, paraprobiotics, and synbiotics on sleep metrics: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
sleep
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of probiotics, paraprobiotics, and synbiotics on sleep metrics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pittsburgh sleep quality index, and other indexes on sleep quality
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Randomized-controlled trials which assessed an impact of probiotics, paraprobiotics, and synbiotics on sleep quality, and which had outcomes of subjective or objective sleep metrics, including pittsburgh sleep quality index
Key exclusion criteria
Review articles, conference abstracts, and non-English and non-Japanese articles.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Division of General Internal Medicine
Zip code
300-0395
Address
3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
+81-29-887-1161
itohirokan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Division of General Internal Medicine
Zip code
300-0395
Address
3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
+81-29-887-1161
Homepage URL
itohirokan@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable.
Address
Not applicable.
Tel
Not applicable.
Not applicable.
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
| 2023 | Year | 03 | Month | 10 | 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 | 03 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We include randomized controlled trials evaluating the effects of probiotics, paraprobiotics, and synbiotics on sleep quality from January 2000 to March 2023 using PubMed and Ichushi. Search terms are: probiotics, paraprobiotics, synbiotics, lactobacilli, bifidobacteria, sleep. In addition, we include research papers evaluating the same content in the reference list of related articles, but exclude review articles, conference proceedings, and non-English and non-Japanese papers. Two researchers independently screened the literature from title abstracts and conducted a full-text review of the extracted research papers. Disagreements regarding literature selection will be resolved by consensus. This systematic literature review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) methodology.
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057556
