UMIN-CTR Clinical Trial

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
Email	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
Email	Tomihken0799@gmail.com

Sponsor
Institute	National Hospital Organization Fukuoka Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032716