UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028846 |
|---|---|
| Receipt number | R000032716 |
| Scientific Title | Study on the effect of oral tolerance induction by early ingestion of powdered milk |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2020/06/22 10:30:28 |
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Basic information
Public title
Study on the effect of oral tolerance induction by early ingestion of powdered milk
Acronym
Study on the effect of oral tolerance induction by early ingestion of powdered milk
Scientific Title
Study on the effect of oral tolerance induction by early ingestion of powdered milk
Scientific Title:Acronym
Study on the effect of oral tolerance induction by early ingestion of powdered milk
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For infants who are at high risk of developing allergies, the incidence of milk allergy is examined in the group who continuously ingested powdered milk, started in the middle, restarted group, and complete breast milk alone group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of occurrence of immediate milk allergy up to one and a half years in each group
Key secondary outcomes
The timing of milk sensitization
Relationship between the amount of milk powder and sensitization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group that had been taking powder milk continuously until 1 year old.
Interventions/Control_2
Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group who was fully breast-fed until 1 year old.
Interventions/Control_3
Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, against the group who started taking milk powder from the middle until 1 year old.
Interventions/Control_4
Blood collection, taking a questionnaire on the state of milk intake and milk allergy occurrence at the age of 1 year and 1 year, agains the group who stopped milk powder halfway and resumed again at the age of 1 year old.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | months-old | <= |
Age-upper limit
| 18 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited our hospital before one year old and one year old
Key exclusion criteria
1) Gestational age less than 37 weeks.
2) There are severe systemic diseases.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Iwata |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Pediatrics
Zip code
811-1353
Address
4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394
TEL
092-565-5534
Tomihken0799@gmail.com
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Iwata |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Pediatrics
Zip code
811-1353
Address
4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394
TEL
092-565-5534
Homepage URL
Tomihken0799@gmail.com
Sponsor or person
Institute
National Hospital Organization Fukuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Fukuoka Hospital
Address
4-39-1 Yakatabaru Minami-ku,Fukuoka Japan 811-1394
Tel
092-565-5534
Tomihken0799@gmail.com
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
| 2017 | Year | 08 | Month | 28 | 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
| 2017 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032716
