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Dietary Pattern Intervention for Neurodevelopment in Preterm Infants

9 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

116

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200062

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Standard Care Group
Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices for 6 months.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Neurodevelopmental Status Assessed by the Gesell Developmental Schedules (GDS)
Tijdsspanne: 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.
Baseline and 6 months post-intervention

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fudan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026R020- F02

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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