UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020100 |
|---|---|
| Receipt number | R000023163 |
| Scientific Title | Effect of lactoferrin ingestion on norovirus infection of food service employees: a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2016/12/07 17:03:46 |
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Basic information
Public title
Effect of lactoferrin ingestion on norovirus infection of food service employees: a randomized, double-blind, placebo-controlled trial.
Acronym
Effect of lactoferrin ingestion on norovirus infection of food service employees: a randomized, double-blind, placebo-controlled trial.
Scientific Title
Effect of lactoferrin ingestion on norovirus infection of food service employees: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
Effect of lactoferrin ingestion on norovirus infection of food service employees: a randomized, double-blind, placebo-controlled trial.
Region
| Japan |
Condition
Condition
Norovirus infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of lactoferrin ingestion on duration of norovirus infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Norovirus infection
Key secondary outcomes
Relapses of gastroenteritis symptoms
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of lactoferrin for 15 days
Interventions/Control_2
Ingestion of placebo for 15 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
1) Subjects in a food service company outsourcing norovirus test to Tokyo Kenbikyoin.
2) Subjects test positive for norovirus more than 3 days after disappearance of gastroenteritis symptoms
Key exclusion criteria
1) Subjects with milk allergy
2) Subjects under 20 years old
3) Subjects in pregnancy
4) Subjects who plan to retire during trial period
5) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc
6) Subjects who consume lactoferrin habitually
7) Subject who are judged inappropriate to this trial by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Ito |
Organization
Incorporated Foundation Tokyo Kenbikyoin
Division name
Director
Zip code
Address
5-1, Toyomicho, Chuo-ku, Tokyo, Japan
TEL
03-3534-2970
ito-t@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ito |
Organization
Incorporated Foundation Tokyo Kenbikyoin
Division name
Director
Zip code
Address
5-1, Toyomicho, Chuo-ku, Tokyo, Japan
TEL
03-3534-2970
Homepage URL
ito-t@umin.ac.jp
Sponsor or person
Institute
Incorporated Foundation Tokyo Kenbikyoin
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 08 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2016 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023163
