UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011577
Receipt No. R000013538
Scientific Title Randomized clinical trial in preventing food allergy Breast feeding vs. breast feeding plus formula milk
Date of disclosure of the study information 2013/09/01
Last modified on 2019/10/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized clinical trial in preventing food allergy Breast feeding vs. breast feeding plus formula milk
Acronym food allergy prevention trial
Scientific Title Randomized clinical trial in preventing food allergy Breast feeding vs. breast feeding plus formula milk
Scientific Title:Acronym food allergy prevention trial
Region
Japan

Condition
Condition infants high risk for atopic sensitization
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare atopic sensitization at 5-6 months and 2 years of age between breastfeeding with or without amino acid milk and breastfeeding with ordinal formula milk
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes atopic sensitization
Key secondary outcomes immediate type of food allergy including anaphylaxis
worsening of atopic dermatitis
desensitization of food allergy
atopic sensitization alone
asthmatic bronchitis
allergic rhinitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 breast feeding (if amounts of breast milk is not sufficient, elemental formula will be added: max 150ml/day) untill starting solid food
Interventions/Control_2 breast feeding + formula milk at least 40 ml per day untill starting solid food
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
0 weeks-old <=
Age-upper limit
104 weeks-old >=
Gender Male and Female
Key inclusion criteria 1. Be in high-risk group of atopic sensitization: at least one of father, mother, brothers and sisters of infants has atopic diseases (asthma, atopic dermatitis, food allergy, allergic rhinitis, hay fever)
2. Obtained informed consent of written form.
a. Participants who understand randomization into two groups: breast feeding with or without amino acid milk and breast feeding with ordinal formula milk.
b. Blood examination at 5 - 6 months and 2 years of age are requisite.
3. Be available to visit outpatient clinic for 7 times at 1 month, 3 months, 6 months, 9 months, 1 year, 1 and half year, and 2 years of age.
Key exclusion criteria 1. Less than 36 weeks of gestational age or less than 2000g of birth weight.
2. Having serious congenital anomalies.
3. Being triple and more: twins may participate in.
4. Abnormal delivery such as asphyxia (Apgar score 6 and less)
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Urashima
Organization Jikei University School of Medicine
Division name Molecular Epidemiology
Zip code
Address Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, JAPAN
TEL 03-3433-1111
Email urashima@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiko Higuchi
Organization Jikei University School of Medicine
Division name Molecular Epidemiology
Zip code
Address Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, JAPAN
TEL 03-3433-1111
Homepage URL
Email bunshiekigaku@gmail.com

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
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
Address
Tel
Email

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 09 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
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 Main results already published
Date of protocol fixation
2013 Year 08 Month 25 Day
Date of IRB
2013 Year 06 Month 08 Day
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2018 Year 05 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
2013 Year 08 Month 26 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013538

Research Plan
Registered date File name
2019/10/29 ABC_Protocol.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/10/29 2019.10.29. Data repository.xlsx


Contact us.