Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
2026年7月9日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
116
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：WenXian Wang, Doctor
- 電話番号：+86 13816964779
- メール：24111020016@m.fudan.edu.cn
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200062
- Shanghai Children's Hospital
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コンタクト：
- Jinjin Chen, doctor
- 電話番号：+86 13816964779
- メール：24111020016@m.fudan.edu.cn
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Parent-Reported Neurodevelopment Assessed by the Ages and Stages Questionnaires, Third Edition (ASQ-3)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年7月1日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月9日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。