UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039115 |
|---|---|
| Receipt number | 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 21:11:28 |
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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
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
tsukat@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Preventive Medicine and Public Health, Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044579
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