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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024654
Receipt No. R000028363
Scientific Title Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2016/10/31
Last modified on 2018/06/21

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Basic information
Public title Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Acronym Effects of fermented milk containing Bifidobacterium in healthy adults
Scientific Title Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym Effects of fermented milk containing Bifidobacterium in healthy adults
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of intake of fermented milk containing Bifidobacterium for 4 weeks in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastrointestinal symptoms at 4 weeks after ingestion of test sample
Key secondary outcomes Psychological symptoms, Breath test, Salivary stress marker, QOL at 4 weeks after ingestion of test sample

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 Treatment
Type of intervention
Food
Interventions/Control_1 Fermented milk containing Bifidobacterium intake
Interventions/Control_2 Fermented milk not containing Bifidobacterium intake
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) Healthy men and women aged from 20 to 64 years old.
2) 8 and over for modified FSSG score.
3) Subjects who understand details of the study and provides informed consent by documents.
Key exclusion criteria 1) Helicobacter pylori infection
2) Subjects who regularly use gastrointestinal drugs.
3) Functional Dyspepsia
4) Subjects who can't stop the ingestion of probiotics, prebiotics, foods containing lactic acid bacteria, bifidobacteria and other healthy foods which may affect gastrointestinal symptoms.
5) Subjects who have food allergy.
6) Subjects who have severe complication or serious diseases requiring an urgent treatment.
7) Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation.
8) Subjects who are judged as unsuitable for the study by the blood test results of screening test.
9) Subjects who are planning to become pregnant during the study or are pregnant or lactating.
10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
11) Subjects who are planning to participate or already participating in other clinical studies.
12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Yakult Honsha Co.,Ltd
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 05 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 10 Month 31 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028363

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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