UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039115
Receipt No. R000044579
Scientific Title The investigation study for the prevention effect of ingestion of lactoferrin-containing yogurt on infectious diseases (infectious gastroenteritis, influenza) in nursery school children.
Date of disclosure of the study information 2020/01/11
Last modified on 2020/01/09 (Ver. 1)

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Basic information
Public title The investigation study for the prevention effect of ingestion of lactoferrin-containing yogurt on infectious diseases (infectious gastroenteritis, influenza) in nursery school children.
Acronym The investigation of preventive effects of ingestion of lactoferrin-containing yogurt on infectious diseases in nursery school children.
Scientific Title The investigation study for the prevention effect of ingestion of lactoferrin-containing yogurt on infectious diseases (infectious gastroenteritis, influenza) in nursery school children.
Scientific Title:Acronym The investigation of preventive effects of ingestion of lactoferrin-containing yogurt on infectious diseases in nursery school children.
Region
Japan

Condition
Condition Infectious gastroenteritis, influenza
Classification by specialty
Medicine in general Gastroenterology Pneumology
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of ingestion of lactoferrin-containing yogurt on the prevention of infectious gastroenteritis and the prevention of respiratory tract infections caused by influenza infection in nursery school children who are at high risk of developing and transmitting infectious diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The group receiving the commercially available yogurt containing lactoferrin and the comparative group were ingested for 3.5 months, and the incidence of infectious gastroenteritis due to norovirus, infectious gastroenteritis due to other causes, and respiratory infection due to influenza was evaluated within the period.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
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 LF group took drink yogurt containing lactoferrin (100 mg) was ingested 5 days (week in principle) / week and 1 bottle / day at breakfast in principle. The intake period was 3.5 months.
Interventions/Control_2 The control group took fruit jelly arbitrarily. The intake period was 3.5 months.
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
3 years-old <=
Age-upper limit
5 years-old >=
Gender Male and Female
Key inclusion criteria 1. Nursery school children (3, 4 and 5 years old)
2. Participants who give sufficient explanation to nursery school children and their parents when participating in the study
Key exclusion criteria 1. Persons with allergy to milk and dairy products
2. Persons who have serious diseases such as circulatory system, liver, kidney, respiratory system, digestive system, blood, endocrine system, metabolic system, etc. or who have a past history and are judged to be inappropriate to participate in the survey
3. Persons who plan to leave the school during the test period
4. The investigator has determined that participation in the study is inappropriate
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Nomiyama
Organization Shinshu University School of Medicine
Division name Department of Preventive Medicine and Public Health
Zip code 3908621
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL 0263-37-2622
Email nomiyama@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Teruomi
Middle name
Last name Tsukahara
Organization Shinshu University School of Medicine
Division name Occupational Health Laboratory, Department of Preventive Medicine and Public Health
Zip code 3908621
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL 0263-37-3582
Homepage URL
Email tsukat@shinshu-u.ac.jp

Sponsor
Institute Department of Preventive Medicine and Public Health, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd,
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Ethics Committee, Shinshu University School of Medicine
Address 3-1-1 Asahi, Matsumoto City, Nagano Prefecture
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.jp

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
2020 Year 01 Month 11 Day

Related information
URL releasing protocol Cannot be entered because a paper is currently being submitted.
Publication of results Unpublished

Result
URL related to results and publications Cannot be entered because a paper is currently being submitted.
Number of participants that the trial has enrolled 1296
Results 
At the end of the study, 1,296 children participated in the study, and 22 withdrew consent during the period, resulting in 1,274 children. Of these, 1,162 subjects from whom all data necessary for analysis could be collected were included in the analysis.
There was no difference in the incidence and severity of infectious gastroenteritis and influenza between the lactoferrin group and the control group.
Results date posted
2020 Year 01 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
With the cooperation of 21 nursery schools, both public and private nursery schools in M city, N prefectures, targeted for 3-5 year old nursery school children.
It is also required that the following exclusion requirements be satisfied.
1 Persons with milk and dairy product allergies

2 Patients with serious diseases in the circulatory system, liver, kidney, respiratory system, digestive system, blood, endocrine system, metabolic system, etc., or those who have a past history and are judged to be inappropriate to participate in the survey

3 Person who plans to leave during the test period

4 Persons whom the investigator judged that participation in the survey was inappropriate
Participant flow 
The purpose of the test was explained to a nursery school in the city with the cooperation of the local government. The test staff then held a test briefing session for parents of 3-5 year olds.
In the test food, the LF group ingested a commercially available LF-containing drink yogurt for 5 days (from Monday to Friday) / week, 1 bottle / day in principle at breakfast, and the control group optionally consumed fruit jelly. The intake status was recorded and confirmed on the intake record slip.
In addition, with the cooperation of pediatrics in the city, when the children who participated in the study were examined during the period for symptoms of infectious gastroenteritis and suspected influenza, a norovirus test and influenza test were conducted. Parents filled out a report with their symptoms and test results when the children were seen for suspected infectious gastroenteritis and influenza.
Adverse events 
No adverse events were identified.
Outcome measures 
1 Incidence　of influenza 

2 Severity of Influenza 

3 incidence of norovirus gastroenteritis

4 Severity of norovirus gastroenteritis

5 Incidence of infectious gastroenteritis other than norovirus

6 Severity of　infectious gastroenteritis 　other than norovirus
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
2014 Year 09 Month 02 Day
Anticipated trial start date
2014 Year 09 Month 02 Day
Last follow-up date
2015 Year 03 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 10 Day
Last modified on
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044579