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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035585
Receipt No. 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 2019/01/18

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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.
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

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 340

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
Institute The Jikei University School of Medicine
Institute
Department

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
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.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


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