UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061887 |
|---|---|
| Receipt number | R000070800 |
| Scientific Title | A single-center randomized controlled trial evaluating the effects of Japanese-style maternal dietary intervention from late pregnancy to one month postpartum on infant gut microbiota and neurodevelopment |
| Date of disclosure of the study information | 2026/06/13 |
| Last modified on | 2026/06/12 13:46:55 |
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Basic information
Public title
A single-center randomized controlled trial evaluating the effect of perinatal maternal dietary intervention on child neurodevelopment
Acronym
ABC3
Scientific Title
A single-center randomized controlled trial evaluating the effects of Japanese-style maternal dietary intervention from late pregnancy to one month postpartum on infant gut microbiota and neurodevelopment
Scientific Title:Acronym
ABC3
Region
| Japan |
Condition
Condition
Pregnant women in late pregnancy to one month postpartum and their infants
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim1:To investigate whether a perinatal dietary intervention with appropriate intake of carbohydrates,lipids,vitamins,and minerals specifically a low fat diet centered on rice and mixed grains,miso soup,fish and seafood,soy products,mushrooms,vegetables,fruits,seaweed,and dairy products promotes infant neurodevelopment,assessed primarily using the Ages and Stages Questionnaires,Third Edition (ASQ-3).
In addition, we aim to examine whether the intervention improves language development assessed by the Japanese version of the MacArthur Communicative Development Inventories(CDI) and reduces the Modified Checklist for Autism in Toddlers (M-CHAT) as secondary outcomes.
Aim 2:To investigate the effects of maternal dietary patterns during the perinatal period, mode of delivery, and exposure to antibiotics on the establishment of the infant gut microbiota.
Aim 3:To investigate how maternal diet affects infant neurodevelopment through breast milk composition and gut microbiota, including analyses by delivery mode and multi-omics approaches.
Aim 4:To identify biomarkers associated with child neurodevelopment by collecting cord blood samples and conducting multi-omics analyses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ages and Stages Questionnaires, Third Edition (ASQ-3)
Outcome 1: ASQ-3 Personal-Social score
Outcome 2: ASQ-3 Communication score
Assessment time point: At 18 months of age (from 17 months 0 days to 18 months 30 days)
Key secondary outcomes
1. Ages and Stages Questionnaires, Third Edition (ASQ-3) at 5 and 12 months of age
Personal-Social domain score and Communication domain score
2. Ages and Stages Questionnaires, Third Edition (ASQ-3) at 5, 12, and 18 months of age
Gross Motor domain score, Fine Motor domain score, Problem Solving domain score
3. Japanese version of the MacArthur Communicative Development Inventories (CDI)
Assessment at 12 and 18 months of age
4. Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F)
Assessment at 18 months of age
5.gut microbiota
6.breast milk composition
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will receive dietary guidance from late pregnancy to one month postpartum, encouraging a diet centered on rice and mixed grains, miso, seafood, green and yellow vegetables, seaweed, soy products, fruits, and mushrooms, while limiting processed meats, fried foods, beef and pork, commercially prepared side dishes, and eating out.
During hospitalization, the use of processed meats will be avoided, and elemental formula will be used when supplementing breast milk with infant formula.
Interventions/Control_2
No restriction group
During hospitalization, the use of processed meats will be avoided, and elemental formula will be used when supplementing breast milk with infant formula.
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.Planned delivery at the Maternal and Perinatal Center of The Jikei University Hospital.
2.Residence within Tokyo's 23 wards and ability to attend follow-up visits at the pediatric outpatient clinic of the Maternal and Perinatal Center of The Jikei University Hospital for health checkups or vaccinations until 18 months of age. Even if continued visits become difficult,communication via email must be possible.
3.The mother has no allergy to rice.
Key exclusion criteria
1.Less than 36 weeks of gestational age
2.Breastfeeding is unavailable by medical reasons
3.Having serious conditions needing admission to NICU
4.Having some conditions needing admission to GCU and charged pediatrician judged the infant hard to participate in this trial.
5.Any other cases in which the principal investigator or study investigators determine that participation in this study is inappropriate.
6.Withdrawal of consent.
7.Strong preference for assignment to the intervention group.
Target sample size
120
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
Division of Molecular Epidemiology
Zip code
105-8461
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
Division of Molecular Epidemiology
Zip code
105-8461
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 Company, Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of The Jikei University School of Medicine
Address
Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
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
| 2026 | Year | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070800
