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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027837
Receipt No. R000031627
Scientific Title Randomized controlled trials involving placebo subjects as to whether infants with atopic dermatitis can reduce the incidence of food allergies after 1 year of age by ingesting multiple foods from early stage
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/26

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Basic information
Public title Randomized controlled trials involving placebo subjects as to whether
infants with atopic dermatitis can reduce the incidence of food allergies
after 1 year of age by ingesting multiple foods from early stage
Acronym Preventive effect of food allergy by ingesting multiple foods from early
stage
Scientific Title Randomized controlled trials involving placebo subjects as to whether
infants with atopic dermatitis can reduce the incidence of food allergies
after 1 year of age by ingesting multiple foods from early stage
Scientific Title:Acronym Preventive effect of food allergy by ingesting multiple foods from early
stage
Region
Japan

Condition
Condition food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preventive effect of food allergy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidence of food allergy
after 1 year of age
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Mix powder containing a small amount of egg, milk, wheat, soybean, buckwheat, peanut /Probiotics
Interventions/Control_2 Probiotics
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
4 months-old <=
Age-upper limit
6 months-old >
Gender Male and Female
Key inclusion criteria Atopic dermatitis diagnosed by a doctor
Key exclusion criteria Child whose birth weight is less than 2500 g or gestational age is less than 37 weeks
Child who had anaphylactic shock by food in the past
Child diagnosed with congenital immunodeficiency
In addition, the child judged to be inappropriate for research researcher
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tatsuo
Middle name
Last name Nishimura
Organization Nishimura Pedeatric Clinic
Division name Division of pediatrics
Zip code 582-0021
Address Kokubuhonmachi 3-9-3, Kashiwara city, Osaka 582-0021 Japan
TEL 072-978-6597
Email tatsuo17@dc4.so-net.ne.jp

Public contact
Name of contact person
1st name Tatsuo
Middle name
Last name Nishimura
Organization Nishimura Pediatric Clinic
Division name Division of pediatrics
Zip code 582-0021
Address Kokubuhonmachi 3-9-3, Kashiwara city, Osaka 582-0021 Japan
TEL 072-978-6597
Homepage URL
Email tatsuo17@dc4.so-net.ne.jp

Sponsor
Institute Nishimura Pediatric Clinic
Institute
Department

Funding Source
Organization Nishimura Pediatric Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nishimura Pediatric Clinic
Address Kokubuhonmachi 3-9-3, Kashiwara city, Osaka 582-0021 Japan
Tel 072-978-6597
Email tatsuo17@dc4.so-net.ne.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
2017 Year 07 Month 01 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 120
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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
2017 Year 02 Month 10 Day
Anticipated trial start date
2017 Year 06 Month 20 Day
Last follow-up date
2018 Year 12 Month 31 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 06 Month 20 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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