UMIN-CTR Clinical Trial

Public title

A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88^TM) intake: A randomized double-blind, parallel-group, placebo-controlled study

Acronym

A study for improving the quality of sleep by lactic acid bacteria SBL88^TM intake

Scientific Title

A verification study for improving the quality of sleep by Lactobacillus brevis SBC8803 (SBL88^TM) intake: A randomized double-blind, parallel-group, placebo-controlled study

Scientific Title:Acronym

A study for improving the quality of sleep by lactic acid bacteria SBL88^TM intake

Region

Japan

Condition

Healthy Japanese adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of Lactobacillus brevis SBC8803 (SBL88^TM) intake on quality of sleep.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. OSA sleep inventory MA version

*Fill it in immediately after waking up at home on the examination day and two days before

Key secondary outcomes

1. Sleep test (Sleep Scan)
2. Athens Insomnia Scale (AIS)
3. Japanese version of Epworth Sleepiness Scale (JESS)
4. Beck Depression Inventory
5. Visual Analogue Scale (VAS) of subjective symptoms

*¹ Perform it at subject's home 1 week before screening and examination and during the test period
*^2-5 Assess these at 0 and 4 weeks after consuming

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4weeks
Test materials: Lactobacillus brevis SBC8803 (SBL88^TM) sterilized lactic acid bacterial cells 25 mg (2.5 x 10¹⁰cells)
Dose: Take a tablet once a day
Administration: Take a tablet at optional timing.
*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 4 weeks
Test materials: Placebo
Dose: Take a tablet once a day
Administration: Take a tablet at optional timing.
*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adults
2. Subjects who feel quality of sleep dissatisfaction
3. Subjects who are judged as eligible to participate in the study by the principal investigator
4. Subjects who are considered as appropriate for the study by the principal investigator based on the score of Beck Depression Inventory
5. Among the subjects who passed 3. and 4., subjects who have a relatively lower score of OSA sleep inventory MA version at screening and examination before ingestion

Key exclusion criteria

1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, and plan to become a pregnant
7. Subjects who live with their infants less than 1 year old
8. Subjects who co-sleep with their children (1 to 6 years old)
9. Subjects who live with requiring long-term care persons
10. Subjects who share the bed with more than one person
11. Subjects who work late-night shift and the life-styles are irregular
12. Subjects whose body mass index (BMI) is 25 kg/m² or more
13. Subjects who wake up for urination 3 times or more during nocturnal sleep
14. Subjects whose dinner time is extremely irregular
15. Subjects who are troubled with pollen allergy or asthma
16. Subjects who drink alcohol heavily
17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
18. Subjects who are judged as ineligible to participate in the study by the principal investigator

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

SAPPORO HOLDINGS LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2017

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

09

Month

11

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

20

Day

Last modified on

2018

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033382