Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
2026년 7월 9일 업데이트: Gengsheng He, Fudan University
Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
116
단계
- 해당 없음
연락처 및 위치
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연구 연락처
- 이름: WenXian Wang, Doctor
- 전화번호: +86 13816964779
- 이메일: 24111020016@m.fudan.edu.cn
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200062
- Shanghai Children's Hospital
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연락하다:
- Jinjin Chen, doctor
- 전화번호: +86 13816964779
- 이메일: 24111020016@m.fudan.edu.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: Standard Care Group
Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices for 6 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)
기간: Baseline and 6 months post-intervention
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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.
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Baseline and 6 months post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3)
기간: Baseline and 6 months post-intervention
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Neurodevelopment will be secondarily assessed using the Ages and Stages Questionnaires, Third Edition (ASQ-3), a parent-completed screening tool.
It evaluates communication, gross motor, fine motor, problem-solving, and personal-social skills.
Higher scores indicate better developmental milestones achievement.
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Baseline and 6 months post-intervention
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Change in Fecal Short-Chain Fatty Acid (SCFA) Concentrations Assessed by Gas Chromatography-Mass Spectrometry (GC-MS)
기간: Baseline, 3 months, and 6 months post-intervention
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Targeted metabolomic profiling will be conducted to quantify fecal SCFA concentrations (primarily acetate, propionate, and butyrate) using Gas Chromatography-Mass Spectrometry (GC-MS).
A quantitative assessment of these microbial metabolites provides insight into gut fermentation capacity.
Data will be reported in micromoles per gram (μmol/g) of wet feces.
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Baseline, 3 months, and 6 months post-intervention
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Change in Fecal Tryptophan-Indole Derivatives Assessed by Liquid Chromatography-Mass Spectrometry (LC-MS)
기간: Baseline, 3 months, and 6 months post-intervention
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Targeted metabolomic analysis using Liquid Chromatography-Mass Spectrometry (LC-MS) will be utilized to quantify the concentrations of specific fecal tryptophan-indole derivatives, which are crucial gut-brain axis signaling molecules.
Data will be reported in nanograms per gram (ng/g) or micrograms per gram (μg/g) of feces.
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Baseline, 3 months, and 6 months post-intervention
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Change in Systemic Inflammatory Cytokine Levels Assessed by Enzyme-Linked Immunosorbent Assay (ELISA)
기간: Baseline, 3 months, and 6 months post-intervention
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Systemic signaling pathways will be evaluated by quantifying the serum concentrations of key inflammatory cytokines (e.g., IL-6, TNF-alpha) using Enzyme-Linked Immunosorbent Assay (ELISA) kits.
Data will be reported in picograms per milliliter (pg/mL).
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Baseline, 3 months, and 6 months post-intervention
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Change in Gut Microbiota Alpha Diversity (Shannon Index) Assessed by 16S rRNA Sequencing
기간: Baseline and 6 months post-intervention
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The composition and diversity of the gut microbiota will be evaluated using 16S rRNA gene sequencing of fecal samples.
Specifically, the Shannon Index will be calculated to assess alpha diversity (species richness and evenness) within individual samples.
A higher Shannon Index value indicates a more diverse microbial community.
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Baseline and 6 months post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 1일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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