UMIN-CTR Clinical Trial

Basic information
Public title	Skin care and synbiotics for prevention of atopic dermatitis or food allergy in newborn infants: A 2 x 2 factorial, randomized, non-treatment controlled trial
Acronym	Prevention study of atopic dermatitis or food allergy in newborn infants with Skin care and synbiotics
Scientific Title	Skin care and synbiotics for prevention of atopic dermatitis or food allergy in newborn infants: A 2 x 2 factorial, randomized, non-treatment controlled trial
Scientific Title:Acronym	Prevention study of atopic dermatitis or food allergy in newborn infants with Skin care and synbiotics
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the prevention of atopic dermatitis or food allergy of Skin care and synbiotics in newborn infants
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence rate of atopic dermatitis in 1-year old
Key secondary outcomes	1) prevalence rate of food allergy in 1-year old 2) Sensitization for food and inhalant allergen in 9 months 3) EASI Score 4) TARC

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Skin care
Interventions/Control_2	Synbiotics
Interventions/Control_3	Skin care and synbiotics
Interventions/Control_4	non-treatment
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	365 days-old >=
Gender	Male and Female
Key inclusion criteria	1) with written informed consent of parents or guardian 2) full-term newborn
Key exclusion criteria	1) premature infant 2) complication of severe underlying disease 3) The neonates who are born by HIV or HBV positive mother 4) any inappropriate status judged by physician.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Shimojo
Organization	Graduate School of Medicine, Chiba University
Division name	Department of pediatrics
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL	043-226-2144
Email	shimojo@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Shimojo
Organization	Graduate School of Medicine, Chiba University
Division name	Department of pediatrics
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL	043-226-2144
Homepage URL
Email	shimojo@faculty.chiba-u.jp

Sponsor
Institute	Department of pediatrics, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japanese red cross katsushika maternity hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Graduate School of Medicine
Address	1-8-1 Ihonana, Chuo-ku, Chiba
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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	2013 Year 05 Month 31 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	2012 Year 09 Month 03 Day
Date of IRB	2011 Year 09 Month 24 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date	2013 Year 05 Month 30 Day
Last modified on	2020 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012665