UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058362
Receipt number R000066721
Scientific Title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality
Date of disclosure of the study information 2025/07/07
Last modified on 2025/07/03 16:24:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality

Acronym

Clinical study to evaluate the efficacy of the bifidobacteria on sleep quality

Scientific Title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality

Scientific Title:Acronym

Clinical study to evaluate the efficacy of the bifidobacteria on sleep quality

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of the bifidobacteria on sleep quality in adults with sleep quality concerns

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sleep quality (EEG)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test food for 8 weeks

Interventions/Control_2

Oral ingestion of the placebo food 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Participants aged more than 20 years, less than 65 years.
2) Participants with a total score of 6 or higher on the Pittsburgh Sleep Questionnaire

Key exclusion criteria

1)Participants with a serious disease or a history of a serious disease
2)Participants with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence
3)Participants who have been diagnosed with sleep apnea syndrome or suspected sleep apnea syndrome (including those being treated with CPAP)
4)Participants who are currently undergoing treatment for sleep, stress, or fatigue, or using medications related to sleep, stress, or fatigue
5)Participants who cannot discontinue intake of food for specified health use, food with functional claims, food with nutrient function claims, supplements, etc. that may affect sleep during the study period
6)Participants who cannot discontinue intake of foods or supplements containing lactobacilli, bifidobacteria, oligosaccharides, etc. during the study period
7)Participants who cannot discontinue intake of caffeine-rich food and beverages, alcohol, or smoking during the period of EEG measurement from 4 hours before bedtime to sleep
8)Excessive alcohol drinkers
9)Excessive smorkers
10)Participants who have more than 3 interruptions of sleep due to urination
11)Participants who do not have fixed days off, who work day and night shifts, and who work shift work (excluding participants who have a fixed work schedule per week as housewives, part-time workers, etc.)
12)Participants who plan to travel abroad during the study period
13)Participants who are participating or intend to participate in other tests
14)Participants with a history of drug allergy or food allergy
15)Participants who may experience allergic symptoms during the study period, or who are using or intend to use drugs for allergic symptoms
16)Pregnant women, intending mothers, and lactating mothers
17)Participants with sensitive skin who may develop skin irritation from adhesive plasters or adhesive tapes
18)Participants who are judged to be inappropriate for this study by the principal investigator or the examination doctor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hisao
Middle name
Last name Nakatani

Organization

Yamaguchi Health Lab

Division name

General manager

Zip code

754-0041

Address

MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.

TEL

083-976-4095

Email

info@yamaguchi-hl.com


Public contact

Name of contact person

1st name Hisao
Middle name
Last name Nakatani

Organization

Yamaguchi Health Lab

Division name

General manager

Zip code

754-0041

Address

MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.

TEL

083-976-4095

Homepage URL


Email

info@yamaguchi-hl.com


Sponsor or person

Institute

Yamaguchi Health Lab

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Conference of Clinical Research

Address

13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo, Japan

Tel

03-6868-7022

Email

jccr-info@jccr.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

2025 Year 07 Month 07 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

Preinitiation

Date of protocol fixation

2025 Year 06 Month 09 Day

Date of IRB

2025 Year 06 Month 20 Day

Anticipated trial start date

2025 Year 07 Month 14 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 07 Month 03 Day

Last modified on

2025 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066721