UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000011577
Receipt number	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 10:58:39

* 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

infants high risk for atopic sensitization

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

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 or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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