Effect of probiotics on the incidence of necrotizing enterocolitis in preterm

• Register: TCTR
• Last refreshed on: 26 May 2025
• Main ID: TCTR20200101001
• Date of registration: 01/01/2020
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine Siriraj Hospital
• Public title: Effect of probiotics on the incidence of necrotizing enterocolitis in preterm
• Scientific title: 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
• Date of first enrolment: 21/07/2019
• Target sample size: 388
• Recruitment status: Unknown
• URL: https://www.thaiclinicaltrials.org/show/TCTR20200101001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Walaiporn Bowornkitiwong
• Affiliation: Faculty of Medicine Siriraj Hospital

• Name: Walaiporn Bowornkitiwong
• Affiliation: Faculty of Medicine Siriraj Hospital

Key inclusion & exclusion 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: - 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

Age minimum: 0 Days
Age maximum: 0 N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Probiotics
Necrotizing enterocolitis
Preterm
Neonatal sepsis

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

Intervention(s)

Probiotics (TS6),Control

Experimental Drug,Sham Comparator No treatment

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 will be fed once daily until postmenstrual age 34 weeks.,Pharmacy will dispense an empty opaque sachet. Formula or breast milk will be injected into the sachet through the small opening. The content will be fed once daily until postmenstrual age 34 weeks.

Primary Outcome(s)

NEC stage 2 or above From enrollment to hospital discharge Clinical diagnosis, abdominal Xray

Secondary Outcome(s)

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

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Interpharma Group

Ethics review

Status: Submitted, approved
Approval date: 27/05/2019
Contact:

[e-mail]

Human Research Protection Unit

024192672 Ext.

[e-mail]

Results

• Date Completed: 30/07/2023