Structured High-Prebiotic Dietary Pattern: Individualized, face-to-face guidance and tailored recipes provided by a registered dietitian, focusing on the scientific introduction of prebiotic-rich complementary foods to promote endogenous beneficial gut bacteria over a 6-month period.
Study summary
The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants. The intervention lasts for 6 months and aims to promote the growth of endogenous beneficial gut bacteria through targeted complementary feeding. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids and tryptophan metabolites), and systemic inflammatory markers.
Eligibility
Sex
ALL
Min age
6 Months
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria:
* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)
* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).
* Corrected age of 6 months ± 7days at the time of enrollment.
* No systemic antibiotic usage within 14 days prior to screening.
* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.
Exclusion Criteria:
* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).
* Severe neurological disorders or structural brain injuries (e.g., Grade III/IV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).
* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).
* Concurrent participation in other interventional clinical trials.
* Planned long-term use of other commercial probiotic/prebiotic supplements outside the study protocol during the intervention period.
* High risk of loss to follow-up (e.g., expected relocation).
Primary outcome measure(s)
Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS) — Baseline and 6 months post-intervention Neurodevelopmental trajectories will be quantitatively evaluated using the Gesell Developmental Schedules (GDS), which yield Developmental Quotients (DQs) across multiple domains (motor, adaptive, language, and personal-social). The DQ is a standardized score; a higher DQ score indicates better neurodevelopmental status and progression.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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