UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054858 |
|---|---|
| Receipt number | R000062682 |
| Scientific Title | A study of probiotic intake on sleep quality in healthy adults with sleep problems -A Randomized, Double-Blind, Placebo Controlled trial- |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/07/17 11:56:08 |
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Basic information
Public title
A study of probiotic intake on sleep quality in healthy adults with sleep problems -A Randomized, Double-Blind, Placebo Controlled trial-
Acronym
A study of probiotic intake on sleep quality in healthy adults with sleep problems -A Randomized, Double-Blind, Placebo Controlled trial-
Scientific Title
A study of probiotic intake on sleep quality in healthy adults with sleep problems -A Randomized, Double-Blind, Placebo Controlled trial-
Scientific Title:Acronym
A study of probiotic intake on sleep quality in healthy adults with sleep problems -A Randomized, Double-Blind, Placebo Controlled trial-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of probiotic intake on sleep quality in healthy adults with sleep problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version
Key secondary outcomes
PSQI-J, AIS, POMS2, Salivary cortisol
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
8-week intake of the probiotics food
Interventions/Control_2
8-week intake of the placebo food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age at least 20 but less than 65 years old at the time of informed consent
2) Those whose global score of PSQI-J at the time of the screening test is between 6 and 10 points
3) Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria
1) Those with serious medical complications or those suffering from illnesses that require urgent treatment.
2) A history of drug allergy or food allergy
3) Those who have chronic diseases (except PMS and menopausal disorders) and are regular users of medications.
4) Persons with gastrointestinal diseases affecting digestion and absorption, and a history of gastrointestinal surgery (except appendicitis).
5) Those with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence.
6) Have a history of sleep apnea (including those being treated with CPAP)
7) Those currently undergoing treatment or using medications related to sleep, stress, or fatigue
8) Those who are unable to discontinue the intake of foods or supplements with health functions, probiotics, or prebiotics during the study period.
9) Those who cannot stop consuming caffeine-rich foods and drinks after 3:00 p.m. during the test period.
10) Excessive alcohol drinker or excessive smokers
11) Frequent nocturia (more than 3 interruptions of sleep due to urination)
12) Those who plan to use drugs due to hay fever or allergic rhinitis
13) Those who do not have a fixed work schedule per week.
14) Pregnant women, intending mothers, and lactating mothers
15) Those who had a blood draw of 400 mL or more within 12 weeks prior to the start of intake, or 200 mL or more during the previous observation period.
16) Persons with sensitive skin who may develop skin irritation due to adhesive plasters or tapes.
17) Those who plan to travel abroad during the test period.
18) Participated, or is participating, or intends to participate, in any other study within the past 12 weeks.
19) BMI greater than or equal to 30 at the time of screening test
20) Persons who test positive for infectious diseases at the time of screening test.
21) Subjects who are judged by the investigator or sub-investigator to be unsuitable for the study based on the results of clinical examinations, etc.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | YOSHITAKA |
| Middle name | |
| Last name | IWAMA |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
Morinaga Milk Industry Co., LTD.
Institute
Department
Personal name
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
日本橋循環器科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 09 | 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
80
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
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062682
