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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name