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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037530
Receipt No. R000042785
Scientific Title A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Date of disclosure of the study information 2019/07/30
Last modified on 2020/01/28

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Basic information
Public title A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Acronym A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Scientific Title A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Scientific Title:Acronym A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of 4-week intake of lactic acid bacteria containing foods on improvement of bowel movement and immune function in healthy volunteers with a tendency to be constipated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency, feeling after defecation, ease of defecation, amount, smell and color of feces, fecal condition (Measure at a daily basis for 1 week during the pre-treatment period, and in the week right before the 2nd, 4th and 6th week when the treatment started)
Activity of NK cell and concentration of IgA in blood
(Measure at before ingestion and after 4-week intake)
Key secondary outcomes Adverse event(Inquiry consultation)
Blood lipid maker
(Measure at before ingestion and after 4-week intake)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Pre-treatment observation period(1 week), treatment observation period, subject take the test food(4 weeks), post-treatment observation period(2 weeks)
Interventions/Control_2 Pre-treatment observation period(1 week), treatment observation period, subject take the placebo food(4 weeks), post-treatment observation period(2 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) Males and females, aged 20 - 65 years old with constipation tendency with defecation frequency 5 times or less per week.
2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1) Subjects who have medical history of malignant tumor, heart failure or myocardial infarction.
2) Subject receiving treatment for gastrointestinal diseases and constipation disease.
3) Currently undergoing treatment for or having a medical history with any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4) Subjects who frequently take medicines for intestinal disorder or laxatives
5) Subjects who frequently take medicines (including herbal medicines)
6) Subjects who are allergic to medicines and/or the test food related products.
7) Subjects with irregular life rhythms such as shift workers, irregular eating habits.
8) Subjects who are pregnant, breast-feeding, or planning to get pregnant.
9) Subjects who have been enrolled in other clinical trials.
10) Subjects who are considered as ineligible to participate in the study by the physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Yamatsu
Organization Pharma Foods International Co., Ltd.
Division name Research and Development department
Zip code 615-8245
Address 1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL 0753948605
Email a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Ishida
Organization Pharma Foods International Co., Ltd.
Division name Research and Development department
Zip code 615-8245
Address 1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL 0753948605
Homepage URL
Email a-ishida@pharmafoods.co.jp

Sponsor
Institute Other
Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization Self-funding
None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Pharma Foods International Research Ethics Committee
Address 1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
Tel 0753948600
Email m-aosasa@pharmafoods.co.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
2019 Year 07 Month 30 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 24
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
2019 Year 04 Month 03 Day
Date of IRB
2019 Year 04 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 30 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 29 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042785

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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