UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015772 |
|---|---|
| Receipt number | R000018354 |
| Scientific Title | A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of fermented milk containing Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion |
| Date of disclosure of the study information | 2014/11/29 |
| Last modified on | 2015/06/17 19:51:34 |
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Basic information
Public title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of fermented milk containing Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion
Acronym
A clinical trial to investigate the effect of Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion
Scientific Title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of fermented milk containing Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion
Scientific Title:Acronym
A clinical trial to investigate the effect of Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of yogurt containing Lactobacillus gasseri SBT2055 (LG2055) on fecal fat excretion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Amount of fecal fat before and after 7-day intake of fermented milk
(Wet weight of feces, Total fecal fat level, Concentration of fecal fat)
Key secondary outcomes
Microbiota of feces before and after 7-day intake of fermented milk
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Fermented milk containing LG2055
100g/day for 7 days
Interventions/Control_2
Fermented milk without LG2055
100g/day for 7 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy males and females over the age of 20 years
Key exclusion criteria
1) Subjects who have frequency of defecation less than 5 days a week
2) Subjects who regularly ingest fermented milk
3) Subject with a history of allergy to medicine and food
4) Subjects who have severe internal organ disorders including coronary heart disease, respiratory impairment, endocrinopathy, or defective metabolism
5) Subjects who have a history of major surgery of digestive system
6) Subjects who consume special health-promoting foods, took medication known to alter lipid metabolism
7)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukuhara Ikuo |
Organization
Fukuhara Clinic
Division name
Medical office
Zip code
Address
3-1-15 Shima-matsuhigashi machi, Eniwa-shi, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Shimpei |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
Megmilk Snow Brand 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
| 2014 | Year | 11 | Month | 29 | 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
| 2013 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 16 | 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
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2015 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
