UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation. Placebo-controlled double-blind randomized crossover comparative study
Title of the study (Brief title)	Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation.
Region	Japan

Condition
Condition	healthy humans
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	tterashima@miula.co.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	MIKI Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028547