A single-center randomized controlled trial evaluating the effect of perinatal maternal dietary intervention on child neurodevelopment

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 - ABC3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061887

Enrollment

120

Registered

2026-06-13

Start date

2026-06-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women in late pregnancy to one month postpartum and their infants

Interventions

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 p

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHaruka Wada

The Jikei University School of Medicine Division of Molecular Epidemiology

wada.haruka519@gmail.com03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026