Probiotics Supplementation for Neurodevelopment in Preterm Infants
Starting soon · Not applicable
Conditions studied: Premature Birth, Neurodevelopmental Disorders, Dysbiosis
In brief
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 facts
- Study ID
- NCT07617181
- Run by
- Fudan University
- People needed
- 116
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-01
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Shanghai Children's Hospital — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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