UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035585
Receipt number R000040537
Scientific Title Primary prevention of food allergy by restricting maternal intake of processed meat and others during first month after birth
Date of disclosure of the study information 2019/01/19
Last modified on 2023/07/23 10:26:33

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Basic information

Public title

Primary prevention of food allergy by restricting maternal intake of processed meat and others during first month after birth

Acronym

ABC II

Scientific Title

Primary prevention of food allergy by restricting maternal intake of processed meat and others during first month after birth

Scientific Title:Acronym

ABC II

Region

Japan


Condition

Condition

Mother and child at risk for atopy

Classification by specialty

Clinical immunology Pediatrics Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Aim1: By conducting randomized controlled trial, we aim to clarify whether food allergy of children by 2 years of age is preventable by restricting maternal intake of processed meat and fish, and others: nuts, ice-cream, butter or buttered food, e.g., croissant, biscuits, cookies, pastry, etc. during first month after birth.
Aim 2: By exploring reactions of cord blood to food allergens and others in vitro, we aim to study mechanisms of sensitization to certain food and of food allergy prevention in the ABC trial during perinatal period.
Aim 3: We aim to study effects of intervention on gut microbiota of infants at birth and during infancy by means of 16s metagenome analyses and components derived from breast milk. Moreover, we aim to investigate whether these gut microbiota and breast milk components are further associating with food allergy.
Aim 4. We aim to examine whether these gut microbiota and breast milk components including intervention in this trial are associating with developmental disorder, i.e., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD) and others.
Aim 5: By conducting randomized controlled trial, we aim to clarify whether autism spectrum disorder (ASD) of children by 2 to 3 years of age is preventable by restricting maternal intake of processed meat and fish, and others: nuts, ice-cream, butter or buttered food, e.g., croissant, biscuits, cookies, pastry, etc. during first month after birth.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

food allergy
1. type I immediate allergic reaction
2. anaphylaxis

Key secondary outcomes

1. Atopic dermatitis
2. Outgrow of food allergy
3. Atopic sensitization
4. Asthmatic bronchitis, asthma
5. Rhinitis
6. Gut microflora
7. Component of breast milk
8. Development
A) CBCL
B) M-CHAT
C) Others
9. autism spectrum disorder (ASD)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are 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

Restricting processed meat group just before delivery to one month of age: restricting maternal intake of processed meat, e.g., ham, salami, sausage, bacon, corned beef, spam can, other canned food, retort food, kamaboko, datemaki, chikuwa, hanpen, tsumire, satsuma-age, etc: peanuts and tree nuts including oil made from these nuts, ice-cream, butter or buttered food, e.g., croissant, biscuits, cookies, pastry, mayonnaise, and eating out, during first month after birth.

Interventions/Control_2

No restriction group

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

20 years-old <=

Age-upper limit

60 years-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, pollen allergy, allergic conjunctivitis) in past or as current status.
2. Participants who understand randomization into two groups either restricting processed meat group or non-restricting group
3. Be available to visit outpatient clinic by 2 years of age.
4. Be available to respond to questionnaires asking health conditions, e.g., doctor diagnosed asthma, by 5 years of age
5. Living in Tokyo and available to visit mother and child center outpatient clinic of Jikei University Hospital.
6. When the infant is suspected to be food allergy and other allergy, he or she can visit outpatient clinic for allergic disease at Jikei University Hospital to take care by specialists for allergy.

Key exclusion criteria

1. Participating pregnant women have fool allergy to egg, nuts, meat, milk
2. Less than 36 weeks of gestational age
3. Breastfeeding is unavailable by medical reasons
4. Having serious conditions needing admission to NICU
5. Having some conditions needing admission to GCU and charged pediatrician judged the infant hard to participate in this trial
6. Having difficulty in communication with mother

Target sample size

210


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Urashima

Organization

The 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 Haruka Wada

Organization

The 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

wada.haruka519@gmail.com


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Ezaki Glico Company, Limited

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

2019 Year 01 Month 19 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

2018 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 18 Day

Last modified on

2023 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name