Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Structured Dietary Pattern Group
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.
干预措施: Structured High-Prebiotic Dietary Pattern (Behavioral)
Standard Care Group
Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices for 6 months.
结局指标
主要结局
Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)
时间窗: 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.
次要结局
- Change in Fecal Short-Chain Fatty Acid (SCFA) Concentrations Assessed by Gas Chromatography-Mass Spectrometry (GC-MS)(Baseline, 3 months, and 6 months post-intervention)
- Change in Fecal Tryptophan-Indole Derivatives Assessed by Liquid Chromatography-Mass Spectrometry (LC-MS)(Baseline, 3 months, and 6 months post-intervention)
- Change in Systemic Inflammatory Cytokine Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)(Baseline, 3 months, and 6 months post-intervention)
- Change in Gut Microbiota Alpha Diversity (Shannon Index) Assessed by 16S rRNA Sequencing(Baseline and 6 months post-intervention)
- Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3)(Baseline and 6 months post-intervention)
研究者
Gengsheng He
Professor, School of Public Health, Fudan University
Fudan University