UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Acronym	Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Scientific Title	Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Scientific Title:Acronym	Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Region	Japan

Condition
Condition	Food Allergy
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of effect of artificial milk on allergy prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of milk allergy at 12 month after birth
Key secondary outcomes	specific IgE of milk and casein at 12 month after birth Frequency of athma, rhinitis, eczema ,food allergy at 24 month after birth specific IgE of mite at 12 month after birth

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	1 days-old <
Age-upper limit	7 days-old >=
Gender	Male and Female
Key inclusion criteria	Neonate within 7days after birth 1, Gestation 37 weeks or more 2, Birth weight 2500g or more 3,babys who can go home within 7 days after birth
Key exclusion criteria	1, congenital anomaly 2, Have difficulty breastfeeding with antiepileptic and antipsychotic drugs 3, Those who do not give their consent to participate in this study
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Hidaka
Organization	University of Tsukuba Hospital
Division name	Pediatrics
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki, JAPAN
TEL	029-853-3900
Email	hitaka-tuk@umin.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hayashi
Organization	Tsukuba Medical Center Hospital
Division name	Pediatrics
Zip code	305-8558
Address	1-3-1 Amakubo, Tsukuba, Ibaraki, JAPAN
TEL	029-851-3511
Homepage URL
Email	hayashi_daisuke@tmch.or.jp

Sponsor
Institute	University of Tsukuba Hospital Depertment of Pediatrics
Institute
Department

Funding Source
Organization	J Milk
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tsukuba Clinical Reserchi and Development Organization
Address	1-3-1 Amakubo, Tsukuba, Ibaraki, JAPAN
Tel	029-853-3914
Email	rinshokenkyu@un.tsukuba.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 03 Month 27 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	Enrolling by invitation
Date of protocol fixation	2019 Year 03 Month 15 Day
Date of IRB	2019 Year 04 Month 08 Day
Anticipated trial start date	2019 Year 04 Month 08 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational birth cohort study Observe relationship between intake of artificial milk and milk allergy.

Management information
Registered date	2020 Year 03 Month 17 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045437