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Probiotics Supplementation for Neurodevelopment in Preterm Infants

23. maj 2026 opdateret af: Gengsheng He, Fudan University

Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial

The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. 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 [SCFAs], and systemic inflammatory markers.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Preterm infants frequently experience delayed or disrupted gut microbiota colonization due to perinatal complications and early-life antibiotic exposure in the Neonatal Intensive Care Unit (NICU). This early-life dysbiosis is increasingly recognized to impact brain development and increase the risk of neurodevelopmental delays through the microbiota-gut-brain axis.This single-blind, randomized controlled trial aims to investigate whether remodeling the gut microbiota via probiotic supplementation can improve neurodevelopmental trajectories. Eligible preterm infants (corrected age of 6 months ± 7days) with a history of neonatal antibiotic use will be randomized into either the probiotic intervention group or the standard care control group. The intervention group will receive a daily oral probiotic mixture containing Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG at a dose of 3*10^9 Colony Forming Units per day (CFU/day) for 6 months.Clinical evaluations, including comprehensive growth monitoring and neurodevelopmental assessments (Gesell Developmental Schedules or ASQ-3), will be conducted. Fecal and blood samples will be systematically collected to analyze gut microbiota diversity and specific metabolic profiles. Specifically, targeted metabolomics will be employed to explore innovative host-microbe signaling. The findings will provide clinical evidence for using microbiota-targeted nutritional interventions to protect early neurodevelopment in vulnerable preterm populations.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

116

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Gengsheng He, PhD

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200062
        • Shanghai Children's Hospital
        • Kontakt:
        • Kontakt:
          • Jinjin Chen, Professor
        • Ledende efterforsker:
          • WenXian WANG, MD
        • Ledende efterforsker:
          • Gengsheng He, Professor
        • Underforsker:
          • YuWei Liu, Professor
        • Underforsker:
          • LiMing Wen, Professor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

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  • Barn

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Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Probiotic Intervention Group
Preterm infants in this group will receive standard care plus a daily oral probiotic mixture for 6 months.
Kosttilskud: Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
Daily oral administration of a probiotic mixture containing Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG at a dose of 3 x 10^9 CFU/day for 6 months.
Ingen indgriben: Standard Care Group
Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices without additional probiotic supplementation for 6 months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Neurodevelopmental Assessment Score
Tidsramme: Baseline and 6 months post-intervention

Neurodevelopmental status evaluated using the Gesell Developmental Schedules (yielding Developmental Quotients [DQs]) or the Ages & Stages Questionnaires, Third Edition (ASQ-3). The reported value in the results data table will be the mean score of the participants in each group.

  • For the Gesell Developmental Schedules: The assessment yields a Developmental Quotient (DQ) for various developmental domains. DQ scores typically range from 0 to over 100, where a score of 100 represents the normative average. Higher DQ scores indicate a better neurodevelopmental outcome (scores below 70 indicate developmental delay).
  • For the ASQ-3: The questionnaire monitors five developmental domains (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social). Each domain is scored from 0 to 60, yielding a total combined score ranging from a minimum of 0 to a maximum of 300. Higher total scores indicate a better neurodevelopmental outcome.
Baseline and 6 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Gut Microbiota Alpha Diversity (Chao1 and Shannon Index Values)
Tidsramme: Baseline and 6 months post-intervention
Evaluation of longitudinal changes in gut microbiota alpha diversity based on 16S ribosomal RNA (16S rRNA) gene sequencing. The results data table will report the mean change from baseline in Chao1 and Shannon indices (dimensionless scores).
Baseline and 6 months post-intervention
Relative Abundance of Specific Gut Microbiota Taxa
Tidsramme: Baseline and 6 months post-intervention
The percentage of key bacterial groups (specifically targeting the supplemented strains Bifidobacterium and Lacticaseibacillus) relative to total sequences, determined via 16S rRNA gene sequencing. The results data table will report the mean relative abundance percentage (%)
Baseline and 6 months post-intervention
Concentration of Fecal Short-Chain Fatty Acids (SCFAs)
Tidsramme: Baseline, 3 months and 6 months post-intervention
Concentrations of specific fecal short-chain fatty acids (including acetate, propionate, and butyrate) quantified using gas chromatography-mass spectrometry (GC-MS) targeted metabolomics. The results data table will report the mean concentration in micromoles per gram (umol/g) of wet feces.
Baseline, 3 months and 6 months post-intervention
Concentration of Systemic Inflammatory Markers
Tidsramme: Baseline, 3 months and 6 months post-intervention
Circulating levels of specific systemic inflammatory mediators (specifically Interleukin-6 [IL-6] and Tumor Necrosis Factor-alpha [TNF-ɑ]) measured in blood samples using Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate host-microbe signaling pathways. The results data table will report the mean concentration in picograms per milliliter (pg/mL)
Baseline, 3 months and 6 months post-intervention

Samarbejdspartnere og efterforskere

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Sponsor

Fudan University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026R020- F01

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

IPD will not be shared to protect the privacy of the infants and their families, as the data includes sensitive medical history and early-life developmental metrics. Furthermore, the dataset contains proprietary information intended for doctoral thesis completion and subsequent intellectual property considerations within the host institution.

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Kliniske forsøg med For tidlig fødsel

Kliniske forsøg med Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)

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