Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

Официальное название

Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial

Обзор

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.

Подробное описание

Preterm infants frequently face early-life gut dysbiosis due to perinatal complications and antibiotic exposure, which may adversely affect their neurodevelopment via the microbiota-gut-brain axis. While exogenous probiotics are one approach, modulating the gut microbiota through endogenous substrates-specifically, structured dietary interventions-offers a sustainable and highly translational alternative.

This single-blind, randomized controlled trial aims to evaluate the efficacy of a structured, high-prebiotic complementary feeding pattern on neurodevelopmental outcomes. Eligible preteum infants (aged 6 to 12 months, corrected age) will be randomized into the dietary intervention group or the standard care control group. Families in the intervention group will receive individualized, face-to-face guidance and tailored recipes from a registered dietitian, focusing on the scientific introduction of prebiotic-rich complementary foods according to the infant's age. The intervention spans 6 months.

Outcomes will be evaluated using the Gesell Developmental Schedules or ASQ-3. Concurrently, fecal and blood samples will be collected to analyze the dynamic shifts in gut microbiota composition and key metabolic pathways . This study will help elucidate whether structured dietary patterns can effectively reshape the gut microbiota and confer neuroprotective benefits in preterm infants.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS) [Срок оценки: Baseline and 6 months post-intervention]

Вторичные конечные точки (5)

• Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3) [Срок оценки: Baseline and 6 months post-intervention]
• Change in Fecal Short-Chain Fatty Acid (SCFA) Concentrations Assessed by Gas Chromatography-Mass Spectrometry (GC-MS) [Срок оценки: Baseline, 3 months, and 6 months post-intervention]
• Change in Fecal Tryptophan-Indole Derivatives Assessed by Liquid Chromatography-Mass Spectrometry (LC-MS) [Срок оценки: Baseline, 3 months, and 6 months post-intervention]
• Change in Systemic Inflammatory Cytokine Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) [Срок оценки: Baseline, 3 months, and 6 months post-intervention]
• Change in Gut Microbiota Alpha Diversity (Shannon Index) Assessed by 16S rRNA Sequencing [Срок оценки: Baseline and 6 months post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shanghai Children's Hospital — Шанхай

Идентификаторы

NCT: NCT07702734 · 2026R020- F02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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