UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016216 |
|---|---|
| Receipt number | R000018770 |
| Scientific Title | A study on the prevention of common cold symptoms and influenza infection by the use of lactoferrin and lactoperoxidase containing food |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2015/12/08 10:59:07 |
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Basic information
Public title
A study on the prevention of common cold symptoms and influenza infection by the use of lactoferrin and lactoperoxidase containing food
Acronym
A study on the prevention of common cold symptoms and influenza infection by the use of LF+LPO containing food
Scientific Title
A study on the prevention of common cold symptoms and influenza infection by the use of lactoferrin and lactoperoxidase containing food
Scientific Title:Acronym
A study on the prevention of common cold symptoms and influenza infection by the use of LF+LPO containing food
Region
| Japan |
Condition
Condition
Common cold and influenza
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the action of the use of lactoferrin and lactoperoxidase containing food for prevention of infections including influenza and reduction of their symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of symptoms of common cold and number of days with the symptoms
Key secondary outcomes
Presence or absence of influenza infection and number of days with its symptoms
Presence or absence of gastrointestinal symptoms and number of days with the symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of lactoferrin and lactoperoxidase containing food for 8 weeks.
Interventions/Control_2
Without intake of lactoferrin and lactoperoxidase containing food 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) Volunteers with age 20-65 years old.
2) Volunteers who belong to Kyushu University of Health and Welfare
Key exclusion criteria
1) Volunteers with milk allergy.
2) Volunteers who are receiving treatment of liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, metabolic system, etc, or who have severe history of at least one of these diseases.
3) Volunteers who are judged to be inappropriate for the study by the principal investigator, collaborative investigator, or collaborative physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kurokawa |
Organization
Kyushu University of Health and Welfare
Division name
Graduate School of Clinical Pharmacy
Zip code
Address
1714-1 Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
b2mk-phoenixacjp@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Kurokawa |
Organization
Kyushu University of Health and Welfare
Division name
Graduate School of Clinical Pharmacy
Zip code
Address
1714-1 Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
Homepage URL
b2mk-phoenixacjp@umin.ac.jp
Sponsor or person
Institute
Graduate School of Clinical Pharmacy, Kyushu University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
九州保健福祉大学大学院医療薬学研究科（宮崎県）（Graduate School of Clinical Pharmacy, Kyushu University of Health and Welfare, Miyazaki）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 20 | 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
| 2015 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 23 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2015 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018770
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| Registered date | File name |
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| Registered date | File name |
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