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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024806
Receipt No. R000028547
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
Date of disclosure of the study information 2016/11/11
Last modified on 2018/07/13

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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