The role of a multi-strain probiotic in very low birth weight infants.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202011513390736

Enrollment

200

Registered

2020-11-11

Start date

2020-11-16

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

Digestive System Neonatal Diseases

Interventions

Labinic probiotic

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female preterm infants (= 27 and < 37 weeks gestational age). Preterm infants with very low birth weight and an extremely low birth weight (<1500g and <1000g). Written maternal consent to the study.

Exclusion criteria

Exclusion criteria: Infants with major congenital malformations and/ or developmental disabilities. Infants born with a laboratory-confirmed bloodstream infection (CRP >10 in the first 36h of life). Infants born <750g (as per Periviability protocol in TBCH, these infants receive only specific supportive measures and no NICU care, and thus poses a high lost to follow-up rate due to high mortality and reduces the statistical validity of the study). Preterm infants with major gastro-intestinal abnormalities or surgery of the gastro-intestinal tract. Preterm infants whose mothers were not available within 72 hours post birth / whose mothers did not want their babies to take part in the study (refusal). If the mother is in the intensive care unit (ICU) that cannot give consent (e.g. ventilated, sedated, delirious or unable to provide consent). Premature infant whose mother gave them up for adoption.

Design outcomes

Primary

Measure	Time frame
Determine the incidence of rectal colonization with MDR-GNB (extended-spectrum beta-lactamases (ESBL) producing or Carbapenem-resistant Enterobacteriaceae (CRE))	—

Secondary

Measure	Time frame
To evaluate the efficacy of a multi-strain probiotic in reducing the incidence and severity of hospital-acquired bloodstream infection in premature infants.;To evaluate the efficacy of a multi-strain probiotic in reducing the incidence and severity of NEC (Bells stage 2 and above) in premature infants.;To evaluate the efficacy of a multi-strain probiotic in reducing the days until full feeds are reached (150ml/kg).;Determine the incidence rate of laboratory-confirmed bloodstream infections (LC-BSI).;To describe the postnatal growth for both probiotic exposed and unexposed premature infants.	—

Measure

Time frame

To evaluate the efficacy of a multi-strain probiotic in reducing the incidence and severity of hospital-acquired bloodstream infection in premature infants.;To evaluate the efficacy of a multi-strain probiotic in reducing the incidence and severity of NEC (Bells stage 2 and above) in premature infants.;To evaluate the efficacy of a multi-strain probiotic in reducing the days until full feeds are reached (150ml/kg).;Determine the incidence rate of laboratory-confirmed bloodstream infections (LC-BSI).;To describe the postnatal growth for both probiotic exposed and unexposed premature infants.

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Countries

South Africa

Contacts

Public ContactEvette van Niekerk

Main study leader

evettev@sun.ac.za27219389474

Outcome results

None listed

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