UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027287 |
|---|---|
| Receipt number | R000031262 |
| Scientific Title | Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2017/05/21 |
| Last modified on | 2018/11/20 17:11:36 |
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Basic information
Public title
Effects of fermented milk containing Bifidobacterium 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 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
YES
Objectives
Narrative objectives1
To evaluate the efficacy of intake of fermented milk containing Bifidobacterium in healthy adults' gut microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota
Key secondary outcomes
1) Fecal properties (water content, pH)
2) Fecal organic acids
3) Uremic toxins
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
Intake fermented milk containing Bifidobacterium for 8 weeks
Interventions/Control_2
Intake placebo for 8 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)Healthy men and women aged from 20 to 65 years old.
2)Subjects whose stool frequency is about 3 to 5 times a week.
3)Subjects who have low relative abundance of bifidobacterium in feces
4)Subjects who have low diversity of microbiota in feces.
5)Subjects who understand details of the study and provides informed consent by documents.
Key exclusion criteria
1)Subjects who regularly use intestinal drugs or laxatives.
2)Subjects who take drugs which affect gut microbiota such as antibiotics.
3)Subjects who have severe complication or serious diseases requiring an urgent treatment.
4)Subjects who have a chronic disease and use medicines constantly.
5)Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation.
6)Subjects who repeat constipation and diarrhea such as irritable colitis.
7)Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria.
8)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
9)Subjects who are planning to become pregnant during the study or are pregnant or lactating.
10)Subjects who are planning to participate or already participating in other clinical studies.
11)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3381
satoru_suzuki@sempos.or.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 The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
| 2017 | Year | 05 | Month | 21 | 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
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 21 | 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
| 2017 | Year | 05 | Month | 09 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031262
