Probiotics Supplementation for Neurodevelopment in Preterm Infants

Sponsor
Fudan University
Study ID
NCT07617181
Status
Not Yet Recruiting

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Conditions

  • Dysbiosis
  • Neurodevelopmental Disorders
  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
23 Weeks - 25 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG) — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Probiotic Intervention Group
    Preterm infants in this group will receive standard care plus a daily oral probiotic mixture for 6 months.
  • No Intervention: 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.

Primary Outcome Measure

Mean Neurodevelopmental Assessment Score [ Time Frame: Baseline and 6 months post-intervention ]

Central Contacts

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