Probiotics in preterm and small for gestational age infants.

Efficacy of probiotic supplementation in preterm and small for gestational age infants. A multi-centre, placebo-controlled, individually-randomised trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202506582053945

Enrollment

2900

Registered

2025-06-19

Start date

2025-11-17

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Paediatrics

Interventions

Probiotic arm

Placebo arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i. < 48 hours of age at the time of enrolment ii. Preterm (AGA or SGA) or term SGA infants iii. Likely to be in the study area for the next 6 months

Exclusion criteria

Exclusion criteria: i. < 28-week gestation ii. Not taking enteral feeds (e.g., due to a major congenital abnormality, mechanically ventilated, post-surgery or too unwell to be fed) iii. Confirmed sepsis at the time of enrolment iv. Indwelling central lines (including umbilical catheter/central venous line) (infants with peripheral intravenous lines will not be excluded) v. Multiple births (e.g., twins, triplets)

Design outcomes

Primary

Measure	Time frame
All-cause mortality;Underweight free survival	—

Secondary

Measure	Time frame
Necrotising enterocolitis;Suspected sepsis;Conformed sepsis;Severe diarrhea;Hospitalization;Underweight;Wasting	—

Countries

Kenya

Contacts

Public ContactBeatrice Olack

Trial Manager

olackb@gmail.com+254721262359

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026