UMIN-CTR Clinical Trial

Public title

Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.
Placebo-controlled double-blind randomized crossover comparative study

Acronym

Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.

Scientific Title

Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.
Placebo-controlled double-blind randomized crossover comparative study

Scientific Title:Acronym

Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.

Region

Japan

Condition

healthy humans

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Verify effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Brain waves during sleep
OSA sleep inventory MA version
Visual Analogue Scale
Number of bowel movements
The days of bowel movements observed
Form of stool
Amount of stool

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of lactic acid bacterium-containing food twice a day for 12 weeks

Interventions/Control_2

Oral ingestion of the placebo control food twice a day for 12 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) 20<=Age<64 of healty men and women
(2) Subjects with a problem for their sleeping
(3) Subjects with a problem for their bowel movements

Key exclusion criteria

(1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases
(2) Subjects with a disorder in heart and lung function
(3) Subjects with abnormal parameters in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease currently under treatment
(6) Subjects with drug or food allergies
(7) Subjects who play high intensity sports or are on a diet
(8) Subjects who are taking supplemental food, quasi drags on drug products (including OTC prescribed medication) that are expected to have improvement effects on bowel movement and sleeplessness
(9) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol for a measurement period of brain waves during sleep and the Actigraph, one day prior to the test day and the day of the test
(10) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period
(11) Subjects who is participating in the other study or planning to participate during the study period
(12) Subjects deemed unsuitable by the investigator for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-6135-5200

Email

tterashima@miula.co.jp

Name of contact person

1st name
Middle name
Last name	Makoto Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

MIKI Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

医療法人花音会みうらクリニック（大阪府）　
Miura Clinic, Medical Corporation Kanonkai（Osaka）

Date of disclosure of the study information

2016

Year

11

Month

11

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

2016

Year

10

Month

11

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

11

Day

Last modified on

2018

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028547