UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005183 |
|---|---|
| Receipt number | R000006154 |
| Scientific Title | Effects of continuous intake of probiotic -fermented milk on risk management of long-term inpatients at health service facilities for the elderly |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2011/03/03 16:59:10 |
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Basic information
Public title
Effects of continuous intake of probiotic -fermented milk on risk management of long-term inpatients at health service facilities for the elderly
Acronym
Effect of probiotic-fermented milk administration for the elderly
Scientific Title
Effects of continuous intake of probiotic -fermented milk on risk management of long-term inpatients at health service facilities for the elderly
Scientific Title:Acronym
Effect of probiotic-fermented milk administration for the elderly
Region
| Japan |
Condition
Condition
long-term inpatients at health service facilities for the elderly
Classification by specialty
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Risk management of infections
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Infections, fever, bowel movement
Key secondary outcomes
Intestinal microbiota and intestinal environment
Serum influenza vaccine antibodies
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The test diet consisted of fermented milk containing Lactobacillus casei strain Shirota (LcS) at 40 billion cells. LcS-fermented milk is made from sugar, skimmed milk, high-fructose corn syrup, and flavor ingredients. It is composed of 62 kcal and contains 1.0 g protein, 0.1 g fat, 14.4 g carbohydrate, 15 mg sodium, and LcS at 40 billion cells or more in each bottle.
Interventions/Control_2
Placebo (The calorie and sweetness of the LcS -free placebo were adjusted with glucose/fructose/liquid sugar so that they were similar to those of LcS-fermented milk. The other materials, components, and appearance were basically matched to those of LcS-fermented milk. The taste/quality were also adjusted so that they were equivalent to those of LcS-fermented milk.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Long-term inpatients at a health service facility for the aged.
Key exclusion criteria
Subjects who cannot ingest the test diets due to intestinal dysfunction.
Subjects who are not suitable for the trial defined by the attending researcher.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University
Division name
Division of Laboratory for Probiotic Research
Zip code
Address
3rd Floor, Hongo-Asakaze Bldg,2-9-8, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-5689-0082
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Nagata |
Organization
Juntendo University
Division name
Division of Laboratory for Probiotic Research
Zip code
Address
3rd Floor, Hongo-Asakaze Bldg,2-9-8, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-5689-0082
Homepage URL
Sponsor or person
Institute
Division of Laboratory for Probiotic Research, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Division of Laboratory for Probiotic Research, Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sosen Hospital
Name of secondary funder(s)
Yakult Honsha Co.Ltd.
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
医療法人社団・誠馨会 総泉病院(千葉県)/ Sosen Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 03 | 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
| 2009 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2011 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006154
