a clinical study to analyse the effectiveness of administration of harmless bacteria in preventing infection of intestine in preterm babies

pre-probiotics therapy for prevention of necrotising enterocolitis (NEC) in preterm infants - a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/003008

Enrollment

220

Registered

2012-09-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- prematurity , necrotising enterocolitis

Interventions

Intervention1: probiotics: bifidobacterium and lactobacilli species- capsule(available as pre pro HS capsules marketed by fourrts limited) one capsule, administered twice a day orally mixed with breas

Eligibility

Inclusion criteria

Inclusion criteria: birth weight > 1000 grams gestational age - 28 - 34 weeks enterally fed

Exclusion criteria

Exclusion criteria: surgical conditions of gastrointestinal tract severe birth asphyxia major congenital malformations chromosomal anomalies

Design outcomes

Primary

Measure	Time frame
incidence and severity of NECTimepoint: during period of hospital stay	—

Secondary

Measure	Time frame
death due to NEC and sepsisTimepoint: during hospital stay	—

Countries

India

Contacts

Public Contactnandhini l p

JIPMER

drnbiswal@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026