Effect of probiotics on the incidence of necrotizing enterocolitis in preterm

Effect of probiotics on the incidence of necrotizing enterocolitis in preterm postmenstrual age less than or equal to 33 weeks and birth weight less than or equal to 1500 g in Siriraj Hospital

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200101001

Enrollment

388

Registered

2020-01-01

Start date

2019-07-22

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing enterocolitis Preterm neonates Neonatal sepsis Probiotics Necrotizing enterocolitis Preterm Neonatal sepsis

Interventions

Pharmacy will dispense TS6 probiotics 3 x 10^9 CFU in opaque sachet. Formula or breast milk will be injected into the sachet through the small opening and will be mixed with probiotics. The content wi

Experimental Drug,Sham Comparator No treatment

Probiotics (TS6),Control

Eligibility

Sex/Gender

All

Age

1 Days to No maximum

Inclusion criteria

Inclusion criteria: - Preterm neonates with postmenstrual age less than or equal 33 wk and birth weight less than or equal 1500 g - Admitted to NICU or intermediate care ward - Able to tolerate feeding at least 1 ml/feed every 3 hours for 8 feeds - Has not received antibiotic for at least 24 hr before enrollment - Parental consent - Physician agrees for the patient to enroll

Exclusion criteria

Exclusion criteria: - Known or suspected immunodeficiency - Inborn error of metabolism - Congenital heart disease except PDA, ASD and VSD - Congenital anomaly of GI tract - Previous NEC stage 2 or 3 - Patients having active infection

Design outcomes

Primary

Measure	Time frame
NEC stage 2 or above From enrollment to hospital discharge Clinical diagnosis, abdominal Xray	—

Secondary

Measure	Time frame
Incidence of neonatal sepsis Within 30 days and 60 days after enrollment or until hospital discharge Clinical diagnosis and blood culture,Hospital mortality rate - -,Time to full enteral feeding - Number of days from enrollment to full enteral feeding (at least 120 ml/kg/day),Incidence of infection due to probiotic strain From enrollment to hospital discharge Clinical diagnosis and culture results	—

Measure

Time frame

Incidence of neonatal sepsis Within 30 days and 60 days after enrollment or until hospital discharge Clinical diagnosis and blood culture,Hospital mortality rate - -,Time to full enteral feeding - Number of days from enrollment to full enteral feeding (at least 120 ml/kg/day),Incidence of infection due to probiotic strain From enrollment to hospital discharge Clinical diagnosis and culture results

—

Countries

Thailand

Contacts

Public ContactWalaiporn Bowornkitiwong

Faculty of Medicine Siriraj Hospital

walbj@hotmail.com0894223604

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026