UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035585 |
|---|---|
| Receipt number | R000040537 |
| Scientific Title | Maternal Dietary Intervention during Early Lactation for Prevention of Food Allergy: The ABC II Randomized Trial |
| Date of disclosure of the study information | 2019/01/19 |
| Last modified on | 2026/08/17 09:47:40 |
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Basic information
Public title
Maternal Dietary Intervention during Early Lactation for Prevention of Food Allergy: The ABC II Randomized Trial
Acronym
ABC II
Scientific Title
Maternal Dietary Intervention during Early Lactation for Prevention of Food Allergy: The ABC II Randomized Trial
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 (added in a protocol amendment approved on December 11, 2023, after the unblinded interim analysis): To explore the association between the randomized maternal dietary intervention and ASD or ADHD diagnoses in children by 36 months of age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative incidence of clinically diagnosed immediate-type food allergy through 24 months of age, including anaphylaxis.
Key secondary outcomes
Exploratory neurodevelopmental outcomes: M-CHAT at 18 months; CBCL at 18 and 24 months; CARS2 at 24 months; and ASD and ADHD diagnoses confirmed by 36 months after evaluation prompted by a positive screening result or other developmental concern documented by 24 months. Between-group comparisons were exploratory because no confirmatory testing hierarchy or multiplicity-adjustment procedure had been prespecified.
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
From admission for delivery through discharge (4 to 6 days postpartum), intervention group mothers received hospital meals excluding processed meat and processed fish and shellfish products, commercially prepared seasoned foods, salt-preserved or canned foods, bread and bakery products, noodles, butter and foods containing butter, nuts, mayonnaise, and ice cream. Rice was served as the staple at each meal: white rice at breakfast and barley-mixed rice at lunch and dinner, together with miso soup, a fish or meat main dish, vegetable or egg side dishes, and fruit. Compared with the standard hospital diet, the intervention diet contained more rice, miso, and other soybean products; less energy from added animal fats and from sugars and sweeteners; a lower percentage of energy from fat (18.0% vs. 23.8%); and a higher polyunsaturated-to-saturated fatty acid ratio (0.80 vs. 0.54). After discharge, mothers were instructed to continue restrictions on processed meat, processed fish and shellfish products, commercially prepared ready-to-eat meals, canned foods, bread and bakery products, butter and foods containing butter, nuts, and ice cream through 1 month postpartum and to avoid dining out during that period. Infants in the intervention group were breastfed; when supplemental feeding was needed, elemental formula rather than cow's milk formula was provided, based on findings from the ABC trial. After discharge, cow's milk formula could be used when supplemental feeding was needed. Mothers completed a daily food diary from discharge through 1 month postpartum.
Interventions/Control_2
Control group mothers received the standard hospital diet from admission for delivery through discharge. After discharge, mothers were instructed to follow their usual diets without restriction. Infants in the control group were breastfed; when supplemental feeding was needed, elemental formula rather than cow's milk formula was provided, based on findings from the ABC trial. After discharge, mothers were instructed to follow their usual diets without restriction, and cow' s milk formula could be used when supplemental feeding was needed. Mothers completed the same daily food diary from discharge through 1 month postpartum.
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
228
Research contact person
Name of lead principal investigator
| 1st name | Mitsuyoshi |
| Middle name | |
| Last name | Urashima |
Organization
The Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
1058461
Address
Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, JAPAN
TEL
03-3433-1111
urashima@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Wada |
Organization
The Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
1058461
Address
Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, JAPAN
TEL
03-3433-1111
Homepage URL
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 Co., Ltd. (collaborating organization for gut microbiome and breast-milk analyses; no financial support or role in clinical-outcome analysis)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine institutional review board
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
Tel
0334331111
rinri@jikei.ac.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
| 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040537
